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Psc Biotech jobs in Los Angeles, CA - 329 jobs

  • Equipment Validation Engineer

    PSC Biotech 3.9company rating

    PSC Biotech job in Los Angeles, CA

    Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role We are hiring motivated and hands-on engineers with direct experience in commissioning, qualifying, and validating pharmaceutical manufacturing facilities, utilities, and large-scale process equipment. This role is critical to ensuring the successful startup and compliance of complex systems used in regulated environments. You will be responsible for developing and executing validation protocols, troubleshooting equipment, and generating comprehensive lifecycle documentation. Develop and execute commissioning, qualification, and validation protocols (IQ/OQ/PQ) for cleanroom environments and large process equipment. Write and review technical documentation including specifications (URS, FS, DS), SOPs, risk assessments, and final reports. Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory expectations. Conduct impact, gap, and risk assessments to identify potential issues and implement mitigation strategies. Analyze test data and acceptance criteria to ensure accuracy and compliance. Operate and troubleshoot equipment during startup and validation phases to assess performance and recommend modifications. Ensure all validation activities meet current industry standards and regulatory requirements (cGMP, FDA, etc.). Additional responsibilities as needed to support project deliverables. Requirements Bachelor's degree in Engineering or a related technical field. 2 - 7 years of hands-on experience commissioning, qualifying, and validating process equipment within the pharmaceutical manufacturing industry. Experience qualifying cleanroom facilities. Experience in large process equipment in pharmaceutical manufacturing (vessels, centrifuges, filter presses and CIP skids). Experienced writing and generating technical validation documentation including final summary reports, IQOQPQ protocols, specifications (URS, FS, DS), operating procedures, etc. Proven knowledge of regulatory requirements and industry standards (cGMP, FDA, etc.). Strong understanding of risk-based validation approach. Excellent analytical, problem-solving, and communication skills. Ability to manage multiple projects and work both independently and collaboratively. Ability to work extended hours At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. Must be authorized to work in the US. No C2C at this time. Benefits Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $85,000 - $100,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RD1
    $85k-100k yearly 10d ago
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  • Robotics Automation Engineer

    PSC Biotech 3.9company rating

    PSC Biotech job in Los Angeles, CA

    PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi -cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role As a Robotics Engineer supporting pharmaceutical manufacturing programs, you will play a key role in designing, developing, integrating, and validating robotic systems used in the preparation and handling of drug‑related components. You will collaborate with cross‑functional engineering, quality, and manufacturing teams to ensure that all robotic solutions meet stringent regulatory expectations and operate safely, reliably, and compliantly in GxP‑regulated environments. Design, model, and prototype robotic mechanisms, actuators, and motion systems appropriate for aseptic and controlled environments. Develop control algorithms, sensor integrations, and automation logic for precise robotic manipulation and handling tasks. Lead system integration activities, ensuring seamless coordination between mechanical, electrical, software, and control system components. Perform risk assessments (FMEA, hazard analyses) aligned with pharmaceutical quality and safety expectations. Support commissioning, qualification, and validation (IQ/OQ/PQ‑aligned testing methodology) of robotic systems in accordance with internal quality systems and regulatory guidelines. Develop engineering documentation, including CAD models, technical specifications, test protocols, validation deliverables, and traceability records. Collaborate with Quality, Manufacturing, R&D, and Automation teams to troubleshoot issues, optimize performance, and maintain ongoing system reliability. Provide technical support for maintenance planning, lifecycle management, and continuous improvement efforts. Ensure all robotic systems comply with FDA, EU, and global GxP expectations related to data integrity, safety, and product quality. Requirements Bachelor's degree in Robotics Engineering, Mechanical Engineering, Mechatronics, Electrical Engineering, or related discipline (advanced degree preferred). 7+ years experience designing, integrating, or validating robotic or electromechanical systems-preferably in a regulated environment (pharma, medical device, biotech, or advanced manufacturing). Proficiency with CAD tools (SolidWorks, Creo, or similar) and experience with motion control, actuators, and sensor integration. Familiarity with programming languages used in robotics (Python, C++, MATLAB, ROS, PLC logic, etc.). Experience contributing to structured validation or testing activities (e.g., system verification, protocol execution, structured acceptance testing). Strong understanding of risk analysis, system safety, and reliability engineering. Excellent communication skills and the ability to work cross‑functionally in multidisciplinary engineering teams. Must be authorized to work in the U.S. No C2C at this time. BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $130,000 - $150,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer -sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI -RT1
    $130k-150k yearly 21d ago
  • Digital Operations Senior Manager - Web

    Genentech 4.5company rating

    Los Angeles, CA job

    ** Why Genentech We're passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity, and creativity while boldly pursuing answers to the world's most complex health challenges and transforming society. Who We Are Digital Experience is shaping the future of how Genentech connects with our patients and customers by harnessing the power of digital innovation and human-centered design. As healthcare evolves, we are bold in our approach - leveraging cutting edge AI, advanced digital engagement, end-to-end content management, and omnichannel technologies and operations to create seamless, personalized, and meaningful experiences for our patients and customers. This is your opportunity to lead transformative change, integrating advanced technology with strategic vision to drive impact at scale. If you are passionate about redefining the healthcare experiences and building something extraordinary, we want you on this journey. Let's redefine what's possible together! This combined team, in collaboration with key partners, builds solutions to serve Marketing, Customer Engagement, Medical Affairs, Public Affairs & Access ("CMG"), and other patient- and customer-facing teams across CMG to shape and drive a seamless, consistent, meaningful, and compliant experience for patients and customers across our interactions. The team is specifically accountable for: ● Defining omnichannel solutions, shaping engagement strategies, designing, operationalizing, and producing seamless, consistent & meaningful patient and customer experiences. ● Accelerating, connecting, and enabling the development of digital solutions that enhance the patient and customer experience across CMG. ● Advancing the mission of seamless, consistent & meaningful patient and customer experiences that maximize patient impact while keeping compliance at the forefront. The Opportunity The Digital Operations Senior Manager - Web is accountable for designing processes and governing operations that allow for the seamless execution of web experiences as part of integrated digital campaigns. This role works closely with the Director, Digital Operations and Business Product Owner to design and build processes that support the Web roadmap and optimal campaign delivery. In addition, this role works to optimize existing processes to ensure maximum efficiency and scale. A successful candidate will have demonstrated experience creating and optimizing standards and solutions, with a focus on optimal customer quality, speed, and cost-effectiveness at scale across a portfolio of products. Key Responsibilities ● Be a valued thought partner by sharing operational insights to influence requirements for new capabilities, product offerings, and the overall product roadmap, where applicable. ● Lead operations when launching products - new features and enhancements , ensuring they are effectively integrated into workflows. ● Explore new ways to improve processes or expand the current capability or product by collaborating with other teams. ● Understand the user experience by developing efficient or automated ways to collect user feedback (e.g., incidents, failures, etc.) and ensure timely resolution, in collaboration with RDT Technical Lead and Customer Experience (CX) team. Communicate status updates to maintain high levels of user satisfaction. Partner closely with Activation to define a mitigation strategy. ● Seamlessly engage the appropriate cross-functional partners, performing regular reviews and updates to products to determine if the process needs to be improved or iterated. Be an advocate for the process. ● Deeply understand operational best practices both within and outside the organization & industry, and develop strategies for implementation across product & user workflows ● Anticipate or surface roadblocks and barriers and develop mitigation strategies to address them proactively and escalate in a timely manner. ● Maintain and support products in their steady state, ensuring quality and usability. ● Leverage deep subject-matter expertise & knowledge of user needs to shape product & process enhancements ● Define and manage Hypercare support resources as needed to support any new feature releases, including automated processes. ● Oversee knowledge management to ensure that all team members have access to the necessary information and resources. ● Engage with Activation and Learning and Skill Development, leveraging deep subject-matter expertise to provide input into stakeholder trainings (AOR, marketing, field members, etc) as necessary. ● Collaborate with other Product Operations Leads and/or Managers to implement and adhere to standardization and consistency in processes and ways of working across Products (when applicable). ● Ensure adherence to in-market error reporting compliance practices. ● Influence Operations Leads and/or Managers to advance overall enterprise operations roadmap (such as workflow, Adverse Event reporting, enterprise campaign delivery, UAT practices, etc). ● Monitor reported issue trends and provide strategic recommendations for the product roadmap to enhance product offerings. Who You Are Minimum Candidate Qualifications & Experience ● Bachelor's degree in business, operations, technology, operations, science, marketing, or a related field, or equivalent experience. ● 5 years of experience in strategy & operations, process operations, product operations, digital operations, or equivalent experience. ● Proven experience in project management and operational support. ● Strong understanding of SOPs and compliance processes. ● Experience with data analytics tools and methodologies. ● Strong problem-solving skills and attention to detail. ● Ability to adapt to new technologies and drive process improvements. ● Experience driving operational excellence through implementation of workflows, automation, scaling, and process optimization. ● Exceptional communication, collaboration, and community engagement skills. ● Proven ability to resolve incidents, gather feedback, and maintain high user satisfaction in a fast-paced environment. ● Strong analytical skills with the ability to monitor and interpret operational data trends and provide actionable insights for improvement. ● Experience overseeing knowledge management and user support initiatives. ● Demonstrated success in managing complex projects involving cross-functional teams and external vendors. Additional Desired Candidate Qualifications & Experience ● Advanced degree, or equivalent experience (e.g., MBA or related graduate-level qualification). ● Experience in the healthcare or pharmaceutical industry or another highly regulated industry. ● Expertise in User Acceptance Testing (UAT) and Quality Control (QC) processes to ensure product reliability. ● Expertise in workflow optimization and automation tools (e.g. Jira), including AI-driven solutions for task management, process enhancement, and seamless collaboration across teams. ● Knowledge of compliance standards and regulatory frameworks relevant to operations and product workflows. ● Demonstrated ability to manage vendor relationships, including Service Level Agreement (SLA) governance. ● Proficiency in leveraging operational data to measure success metrics (e.g., speed, cost, quality) and improve performance. ● Understanding of privacy compliance frameworks (e.g., OneTrust, GDPR, CCPA) as they relate to web and mobile operations. Location ● This position is based in South San Francisco, CA, however a remote work option will be considered for US candidates who live outside of the Bay Area. _The expected salary range for this position based on the primary location of South San Francisco, CA is $136,100 and $252,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below._ Benefits (**************************************************** \#LI-NN2 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $136.1k-252.7k yearly 6d ago
  • 2026 Summer Research Intern, LLM and Generative AI - BRAID

    Genentech 4.5company rating

    Los Angeles, CA job

    2026 Summer Research Intern, LLM and Generative AI - BRAID Genentech, a biotechnology leader, seeks an outstanding machine learning intern to contribute to cutting-edge research at the Deep-Learning Theory and Algorithms (DELTA) and Regulatory Language Understanding (ReLU) labs within the Biology Research | AI Development (BRAID) department in the Computational Sciences Center of Excellence (CS-CoE). Our labs are dedicated to advancing machine-learning research to support drug discovery efforts, focusing on foundational models, LLMs, and generative AI, particularly in the realms of Agentic AI, multi-modal settings, instructional tuning, and knowledge retrieval. We are committed to driving innovation through cutting-edge ML methods with real-world impact in genomics research and drug discovery. The new Computational Sciences Center of Excellence (CoE) is a strategic, unified group whose goal is to harness the transformative power of data and Artificial Intelligence (AI) to assist our scientists in both pRED and gRED to deliver more innovative and transformative medicines for patients worldwide. This internship position is located in South San Francisco, on-site. Position Overview: Join us for a 12-week summer internship (full-time, 40 hours per week) in 2026 at our South San Francisco location (on-site). The start date can be May 18 or June 1, offering an exciting opportunity to work alongside our collaborative research team of machine learning scientists, computational biologists, and chemists, and make a substantial contribution to the field. The Opportunity * Research, design, and implement novel cutting-edge research in AI with applications to drug discovery. * Drive research on (large-scale) generative AI methods for scientific challenges. * Collaborate closely with cross-functional teams across gRED to tackle complex problems. * Contribute to and lead publications, presenting results at internal and external scientific conferences, and making code and workflows open source. Program Highlights * Intensive 12-weeks, full-time (40 hours per week) paid internship. * Program start dates are in May 18 or Jun 1, 2026 * A stipend, based on location, will be provided to help alleviate costs associated with the internship. * Ownership of challenging and impactful business-critical projects. * Work with some of the most talented people in the biotechnology industry. Who You Are Required Education Must be pursuing a PhD (enrolled student). Required Majors Computer Science, Electrical Engineering, Statistics, Computational Biology or a closely related field with a core academic focus on machine learning, artificial intelligence and computational theory. Required Skills: * Enrolled in a PhD program where your core focus is on machine learning, artificial intelligence, computational theory, or a related field. * Proven publication record in top ML conferences (e.g., NeurIPS, ICML, ICLR). * Strong expertise in Generative AI and LLMs. * Advanced programming skills in frameworks such as PyTorch, TensorFlow, or JAX. * Excellent communication and teamwork skills. Preferred Knowledge, Skills, and Qualifications: * Familiarity with AI agents, fine-tuning methods (e.g., SFT, RLHF, RL with experimental feedback), prompt engineering, PRM, and LLM calibration techniques. * Familiarity with ML topics such as uncertainty quantification, conformal prediction, or offline RL. * Experience in developing and applying Generative models for scientific applications. * Knowledge of biological domains such as sequence design, perturbation biology, or target discovery. Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of CA is $50.00 hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $50 hourly 6d ago
  • Director, Field Medical Integrated Enablement & Engagement Process Lead (EPL)

    Genentech 4.5company rating

    Los Angeles, CA job

    ** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. **The Opportunity** The Director, Integrated Enablement & Engagement Process Lead (EPL) is a critical member of the Field Medical team, collaborating with the US Medical Digital team. This individual is instrumental in defining, aligning, and embedding digital, data, and analytics capabilities to not only meet current business needs but also proactively address and anticipate future needs. Acting as a key connector and central liaison between Field Medical and product teams, this role provides strong user understanding, workflow expertise, and product ecosystem knowledge to effectively embed tools within a complex, matrixed organization. Simultaneously, this role coordinates directly with users to drive successful user adoption of new digital capabilities and initiatives. This role plays a strategic part in identifying business needs, shaping product direction and prioritization, and integrating products into new and existing workflows to maximize impact in Field Medical. Furthermore, this role drives the planning and execution of change management, knowledge sharing, training, and adoption, as well as understanding and measurement activities, in partnership with Operational Excellence teams. This role requires a deep understanding of Field Medical priorities, standards of excellence, compliance, and the ability to intuitively manage, inspire, and build trust within a matrixed organization. **Key Responsibilities** + Strategic Liaison & Stakeholder Engagement: Serves as the primary point of contact for Field Medical capability needs, collaborating with cross-functional stakeholders to identify, synthesize, and prioritize user feedback, and ensuring end-to-end excellence across Field Medical digital and AI initiatives. + Workflow Design & Process Integration: Accountable for seamless integration of new digital products into workflows, serving as a subject matter expert to identify capabilities, validate requirements, and lead process changes to optimize workflows. + Enablement & Support: Develops and implements strategies to drive awareness and adoption of new tools, champions change management, and designs and delivers comprehensive training. + Change Leadership & Continuous Improvement: Leads complex change initiatives, drives organizational change from current to future state, and continuously partners with stakeholders to ensure alignment on priorities. + Measurement & Optimization: Regularly assesses and reports on the health of Field Medical operations, collaborates with partners to establish KPIs, and synthesizes measurement insights and user feedback into actionable learnings. + Compliance & Governance: Establishes robust project governance frameworks, ensures adherence to regulatory compliance and privacy standards, and builds relationships with legal and compliance partners. **Who you are** **Qualifications & Experience** + Bachelor's degree + A minimum of 8 years of work experience, with at least 6 years of experience in the pharmaceutical or biotech industry, including 2 years in Healthcare Business Analytics. + Experience in machine learning, deep learning, AI techniques, and building impactful data visualizations for medical decision-making (e.g., using Spotfire , Tableau, and RShiny). Strong data proficiency with a deep understanding of data strategy, technology, and platforms. + Strong ability to work across functions in matrixed environments, providing strategic guidance, engaging stakeholders on data and visualization needs, and influencing senior leadership without direct authority. + Experience with sole ownership of tactics or pieces, ability to articulate business problems, identify solutions, and own content development from strategy through execution. Demonstrated experience with strategic planning, prioritizing, and management of high-level initiatives and projects. + Strong understanding of the healthcare landscape and customer types (health systems, payers, providers, HCPs, patients, IDNs, distributors, pathways), and how they operate their businesses. **Preferred Qualifications & Experience** + MBA or other related graduate-level degree + 5+ years of experience in clinical development with strong skills in clinical trial data analysis, RWD assets. + Six sigma, PMP, or similar certifications + Proven ability to embed products, embrace agile methodologies, and effectively organize for impactful outcomes, while continuously investing in personal development. + Demonstrates an enterprise and execution mindset, thriving in ambiguous, transformational environments with adaptive and critical thinking. + Exhibits inspiring, visionary, customer-first leadership, strong business acumen, excellent presentation, interpersonal, and communication skills, alongside highly proficient project planning and oversight. **Location & Travel Requirements** The role is field-based, with a minimum of 30% of the time expected to be spent in the office in South San Francisco, CA, or traveling to locations designated by the Business. The expected salary range for this position based on the primary location of South San Francisco, CA is $136,100 - 252,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (**************************************************** Relocation benefits are not available for this job posting Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $136.1k-252.7k yearly 60d+ ago
  • 2026 Summer Intern - Discovery Chemistry

    Genentech 4.5company rating

    Los Angeles, CA job

    ** **2026** **Summer** **Intern -** **Discovery Chemistry** The Discovery Chemistry department drives early-stage therapeutic innovation by designing and synthesizing novel small molecules. Our team focuses on creating drug candidates that precisely modulate biological targets to treat serious diseases. We are at the forefront of pioneering new chemical matter that ultimately forms the foundation for Genentech's next generation of medicines. This internship position is located in **South San Francisco, on-site.** **The Opportunity** + Interface with industrial chemists to explore and refine chemistry towards scaffolds relevant to medicinal chemistry. + Perform hands-on synthetic work and optimization where necessary to advance an internship project. + Gain experience with chemical synthesis techniques, including chemical catalysis and reactions essential to a professional career in medicinal chemistry. + Apply critical thinking and problem-solving to achieve project goals. + Contribute to Genentech's culture of scientific curiosity and discovery via cross-department presentations. **Program Highlights** + **Intensive 12-weeks, full-time (40 hours per week) paid internship.** + **Program start dates are May/June, 2026.** + **A stipend, based on location, will be provided to help alleviate costs associated with the internship.** + Ownership of a challenging and impactful project. + Work with some of the most talented people in the biotechnology industry. **Who You Are** **Required Education:** Must be pursuing a Bachelor's Degree (enrolled student). **Required Majors:** Chemistry, Biochemistry, or a related field. **Required Skills:** + Experience with multi-step small molecule organic synthesis. + Familiarity with modern techniques for small molecule purification and analysis (NMR, LCMS). **Preferred Knowledge, Skills, and Qualifications** + Excellent communication, collaboration, and interpersonal skills. + Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion. **Relocation benefits are not available for this job posting.** The expected salary range for this position based on the primary location of California is $29.00-$33.00 hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $29-33 hourly 7d ago
  • Metrology Field Service Technician

    PSC Biotech 3.9company rating

    PSC Biotech job in Pomona, CA

    PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi -cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role As a Metrology Field Service Technician, you will be the executor of measurement-focused on the precise, meticulous execution of validated procedures and the maintenance of environmental and equipment integrity. You will perform on‑site calibrations and validations for PSC Biotech and client facilities, serve as the point of contact while on‑site, and provide technical support and troubleshooting to ensure measurement validity and compliance. Perform high‑accuracy calibration and functional testing in accordance with established procedures and applicable standards (e.g., ISO/IEC 17025: 7.1). Strictly monitor and log laboratory and work‑area conditions (temperature, humidity, differential pressure, etc.) to maintain measurement validity. Execute scheduled preventive maintenance and checks on primary/reference working standards and ancillary equipment; escalate out‑of‑tolerance conditions per approved procedures. Perform on‑site calibrations, execute work orders, and complete service documentation with a high attention to detail and adherence to safety protocols. Conduct on‑site validations and support projects as assigned, coordinating schedules and deliverables with project leads. Manage and transport metrology equipment and standards for on‑site/project support in accordance with handling and chain‑of‑custody requirements. Serve as the primary on‑site point of contact; interface with client end‑users and their internal support teams to plan, access, and execute scope safely and efficiently. Perform calibrations independently, interpret results, and provide technical support and practical solutions to resolve issues. Coordinate engagement meetings with clients on behalf of the Metrology Manager to align scope, timelines, and deliverables. Perform troubleshooting and minor repairs within approved authority; document findings and recommend corrective actions. Requirements Bachelor's degree in Engineering, Metrology, Industrial Technology, Electronics, Life Sciences, or a related technical discipline is required. 4+ years experience performing calibrations using validated procedures on primary and reference standards in a GMP/GLP or ISO‑accredited environment. Working knowledge of ISO/IEC 17025 principles, measurement traceability, and uncertainty. Demonstrated ability to perform calibrations independently, troubleshoot instrumentation, and recommend technical solutions. High attention to detail in measurement execution, data recording, and documentation accuracy. Ability to strictly monitor and log environmental conditions (e.g., temperature, humidity) to ensure measurement validity. Experience performing preventive maintenance and integrity checks on working standards and metrology equipment. Experience interfacing directly with client end‑users, facilities personnel, and internal technical teams. Capable of serving as the primary point of contact while on‑site and coordinating engagement discussions on behalf of the Metrology Manager. Ability to work independently in a fast -paced environment. Ability to travel to client sites across the U.S. to support project and calibration activities (travel percentage varies by assignment) Must be authorized to work in the U.S. No C2C at this time. BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24 -Hour Fitness, and more). Financial Perks and Discounts Adhering to the requirements of California's law on pay transparency, the salary bracket for this role is set between $75,000 to $95,000. The offered rate can be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer -sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI -RD1
    $75k-95k yearly 23d ago
  • Regulatory Affairs Specialist

    Medtronic 4.7company rating

    Los Angeles, CA job

    We anticipate the application window for this opening will close on - 17 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the LifeIn this dynamic role as a Regulatory Affairs Specialist, you will be responsible for informing both local and global regulatory partners of sustaining changes through the Medtronic Agile system. Reporting to the Regulatory Affairs Manager, you will collaborate with various cross-functional teams, including Supplier Quality, Sourcing, R&D, Manufacturing, and Labeling, among others. Your daily activities will involve regulatory writing for internal stakeholders to efficiently document sustaining changes while ensuring comprehensive coverage. Additionally, you will coordinate with global partners on projects requiring supplementary information. This role primarily focuses on Change Management activities for sustaining Medtronic's Diabetes products. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. Responsibilities may include the following and other duties may be assigned. Coordinate and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections. Compile materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Must Have: Minimum Requirements Minimum 2 years of experience with a Bachelor's Degree Or, advanced degree Nice to Have (Preferred Qualifications): Master's degree Experience at Medtronic Non-conformance Material Report (NCMR) or Product Review Board (PRB) experience. Experience in the medical device industry/manufacturing. Knowledge of EU MDR and US FDA Regulations Medical Device Lifecycle Good Documentation Practice (GDP) ISO 13485 Experience writing FDA annual reports Change Assessment Project Management experience Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$73,600.00 - $110,400.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
    $81k-107k yearly est. Auto-Apply 2d ago
  • SAP System Process Specialist (CVRM)

    Genentech 4.5company rating

    Los Angeles, CA job

    ** ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). **The Opportunity** A System Process Specialist is being hired to participate in Greenfield Project execution and then support the facility after going live. The role will become member of SAP deployment team for Holly Springs and post go live become site first level support. Candidate will bring experience from one or more of following L4 business processes: EWM (Warehouse), Make, Plan, Asset, Quality Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. **What You'll Do** A Systems Process Specialist acts in the 1-Stop-Shop and is part of the support, continuous improvement and onboarding and adoption value streams. The Systems Process Specialist has a profound process understanding and is collaborating with the Business Support Community to continuously improve business processes and underlying IT applications. By this, he/she acts as a trusted adviser of the end-user for any kind of inquiry as well as a bridge between the end user and other roles in the various support layers and can raise incidents on behalf of the user area or work with managers to train users . The role is specialist on a specific operation process area and is providing end-user support based on in-depth and long time professional experience in this domain. Examples of domains include Plan, Make, Quality, EWM (Warehouse), Assets etc. In projects the Systems Process Specialist can also represent the interests of the systems user group and has the responsibility of coordinating and bringing input from the area of responsibility to the project and communicating project goals, information and progress back to the business areas. End User Operation Support + Performs Level 1 On Site/Remote support and troubleshooting of applications, primarily focused on SAP R3 and ASPIRE but could expand to PI, MES, etc. + Acts as Point of Contact for End User/business stakeholders in terms of business requests and IT related issues. + Triages, prioritizes requests and tries to identify the nature / root cause of an issue (handling issue, data issue, authorization issue, IT issue). + Distributes application issues and non-application issues that cannot be solved by him/her to the 2nd level and/or Global Team support. + Coordinates end user groups and escalation management. Follows up on IT Service tickets to resolve issues in a timely manner. Supports issue clarification on request of 2nd level and/or Global Team support. + Validates the resolution proposals and performs the necessary test in case tests are required. + Cooperates with 2nd level and/or Global Team support during analysis of reported incidents. + Maintains close coordination and communication with End User/site business stakeholders for major incidents. + May be a role owner for local roles. + Performs interface monitoring (business errors). + Executes complex or critical system actions. + For new IT initiatives/product/system roll out/Go Live to site, provides on site/remote on call support per business requirement such as adopting business shift pattern during initial roll out and stand down to remote On Call post Hyper Care after successful roll out. + Supports Global/Enterprise and Local ITOT application/systems. + Supports site audits and inspections, planned/unplanned events, and implementation of corrections, etc. as a Subject Matter Expert. + Provides 24x7 routine operation service support per Service Level Agreements to business. + Adheres to the requirements specified in IT related Roche's quality policies/quality standards or related SOP. Continuous Improvement + Supports/Leads Continuous Improvement opportunities related to ITOT applications/system. + Regular exchange with the Support network and or BPMs on support cases, best practices and process improvement proposals with network relevance. + Helps the End User to submit new ideas for process improvements, allowing a comprehensive approach for assessing both the process interdependencies as well impact to all underlying systems. + Describes the full lifecycle of an integrated Change process to Business Process with System impact. This Framework combines the Assessment of the requirement, Build and Test work as well as Deployment and eventually delivery of the added value to the End User. + Embodies PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives. Onboarding & Training + Coordinates and conducts End User training. + Supports user authorization workflows (e.g. request, verify training, approve). + Adds information to the knowledge base. + Creates/Reviews Knowledge Articles. + Creates/Reviews training material. + Initiates knowledge management process. **Who You Are** + Bachelor's degree in Informatics, Engineering, or equivalent. + 5+ years of experience with SAP R3. + Experience or familiarity with ASPIRE is a plus. + Must have experience in biotech/pharmaceutical manufacturing GMP domain. + Knowledgeable about integration with enterprise business systems (SAP, MES, LIMS, etc.) and data integrity concepts. Soft Skills + Strong analytical skills for effective troubleshooting and problem solving. + Candidates must be self-driven and able to work well with others as a team member. + Strong technical writing and verbal communication skills. + Excellent customer service skills and delivery through agile mindset, stability, flexibility, and speed. + Passion for learning and sharing/leveraging best practices. + Eager to explore new technology and have the ability to learn new concepts. **Relocation Funding is not available for this role.** The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $80,500 - $149,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (**************************************************** Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $80.5k-149.5k yearly 60d+ ago
  • Director Program Mgmt Launch PMO

    Edwards Lifesciences Corp 4.6company rating

    Irvine, CA job

    Director Launch, PMO Make a meaningful difference to patients around the world. Our project management teams support many parts of Edwards, including Engineering, HR, Marketing, IT, and more. You'll be a trusted thought leader as you ensure our projects are completed efficiently and effectively. Your strategic mindset and fresh perspectives will be an essential part of how we bring innovative solutions for patients. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. Position Summary: The Director of Launch PMO - TMTT will lead a team of Launch Project Managers focused on project management excellence of global commercial launches across all mitral and tricuspid therapies and geographies. Work Schedule: This is an onsite position in Irvine, CA. How you will make an impact: * Partner with Marketing, Commercial Sales, Operations and other launch stakeholders to execute a global launch best practices from previous launches, launch team roles & responsibilities, and other templates to support excellent launch planning and execution * Elevate, Develop and Lead a Launch PMO team, who will: * Enthusiastically work collaboratively across the broader PMO groups and extended launch teams * Develop and implement detailed project plans collaboratively with the launch team and implement methods to track status of launch efforts * Partner with the Marketing Launch Heavy Weight Team Leads (HWTLs) and global launch stakeholders to ensure effective cross-functional launch execution, and * Communicate effectively with key launch stakeholders * Facilitate, lead and own Launch Steering Committee / Review Board meetings enabling high decision quality for launch projects and driving alignment among TMTT Leadership Team on launch decisions * Act as strategic thought partner to TMTT Leadership Team representing go-to-market strategies for various global launch projects * Develop and establish credibility with global launch teams as a key partner through product and launch knowledge * Up to 25% Travel What you will need (required): * Bachelor's degree in related field * Related experience in project/program management or equivalent work experience based on Edwards criteria * Hands-on experience managing large to midsize projects and/or programs of increasing complexity or equivalent work experience based on Edwards criteria * Demonstrated track record in people management What else we look for (preferred): * Minimum 12 years of experience in program management OR Master's degree and a minimum 10 years of experience in program management * Executive presence * Experience working in a regulated industry * Proven successful project management leadership skills * Experience leading and managing teams * Excellent verbal and written communication skills * Strong organizational skills and the ability to build effective working relationships * Strategic, critical thinker with the ability to address complex problems * Experience building organization capabilities and affecting organizational change * Ability to lead and thrive in a dynamic, fast-paced environment * Advanced degree and/or experience in Marketing * Previous commercial launch experience * PMP Certification * MBA * Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $156,000 to $221,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $156k-221k yearly Auto-Apply 3d ago
  • Senior Cyber Information Assurance Analyst

    Medtronic Inc. 4.7company rating

    Irvine, CA job

    We anticipate the application window for this opening will close on - 16 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In your role, you may work from the following Medtronic sites: * Mounds View, Minnesota • Boston, Massachusetts * Fridley, Minnesota (OHQ) • Lafayette, Colorado * Irvine, California (UCI) • Jacksonville, Florida * Rice Creek, Minnesota The Medtronic Global Cyber and Information Security Office (GCISO) is seeking a highly skilled and experienced Senior Cybersecurity Information Assurance Analyst to join our cybersecurity team. In this role, you will be responsible for leading the identification, assessment, and mitigation of cybersecurity risks across the organization. As a senior member of the team, you will provide expertise in risk management, compliance, and security strategy, while also playing a key role in driving initiatives to ensure the protection of sensitive data, particularly in a highly regulated healthcare environment. You will collaborate with cross-functional teams to evaluate and enhance our cybersecurity posture, ensuring adherence to relevant regulations such as HIPAA, GDPR, and other industry standards. We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communications to achieve long-term sustainable impact. Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world. Bring your talents to an industry leader in medical technology and healthcare solutions - we're a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We encourage and support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Join us for a career in IT that changes lives. Medtronic is committed to fostering a diverse and inclusive culture. Check out the accomplishments of our Women in IT group! ******************************** At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned. * Defines requirements for business continuity, operations security, cryptography, forensics, regulatory compliance, internal counter-espionage (insider threat detection and mitigation), physical security analysis (including facilities analysis, and security management) to best protect company assets. * Assesses and mitigates system security threats and risks throughout the program life cycle. * Validates system security requirements definition and analysis. * Implements and validates security designs in hardware, software, data, and procedures. * Verifies security requirements; performs system certification and accreditation planning and testing and liaison activities. * Understanding of Identity, Lifecycle and Governance capabilities, intersection with other cyber security domains, products and industry practices. * Identify and assess cybersecurity risks through business analysis and propose solutions to mitigate those risks, contributing to overall business continuity and security resilience. * Demonstrated expertise in GRC frameworks and processes, including system selection, system administration, and supporting core GRC functions. Lead the design and implementation of process flows, ensuring alignment with business objectives. * Collaborate with teams across various departments, including IT, legal, compliance, and product security, to identify, assess, and mitigate cybersecurity risks across a broad range of products and services, ensuring security is integrated throughout the entire product lifecycle and operational processes. * Maintain up-to-date knowledge of cybersecurity regulations and standards specific to the medical device industry (FDA, HIPAA, IEC 62443, NIST, NIS 2, etc.). * Drive improvements in the GRC platform by automating workflows, integrating new tools, and optimizing risk management processes to increase operational efficiency and reduce manual effort. Minimum Requirements 4+ years of experience with a with a high school diploma or equivalent. NICE TO HAVE (Preferred Qualifications) * Previous Medtronic experience * 7+ years of experience in cybersecurity GRC (Governance, Risk, & Compliance), or external/internal audit, preferably within the medical device or healthcare industry. * Strong understanding of cybersecurity frameworks, regulatory requirements, risk management, and industry best practices (e.g., HIPAA, NIST, ISO 27001, GDPR, etc.). SKILLS & COMPETENCIES * Excellent communication and interpersonal skills, with the ability to interact effectively with both technical and non-technical stakeholders. * Ability to think critically and strategically about risk management and how technology, process improvements, and automation can help the organization proactively address cybersecurity risks. * Excellent presentation skills with the ability to communicate complex risk management concepts clearly to executive-level audiences, translating technical details into actionable insights for senior leadership. RISK MANAGEMENT EXPERIENCE * Minimum 5 years of experience executing key risk management activities, including conducting risk assessments using various quantitative and qualitative methodologies, such as the FAIR model (Factor Analysis of Information Risk), ensuring a deep understanding of risk analysis methodologies. * At least 3 years of active participation in the design and implementation of at least 2 comprehensive risk management programs (e.g., risk assessments, regulatory assessments) within a large, complex organization, including hands-on experience with program execution and improvement. * Proven expertise in process design and improvement related to risk management frameworks and methodologies, ensuring effective risk mitigation strategies are incorporated into operational processes. * Experience conducting NIST risk assessments (e.g., NIST CSF, NIST 800-53) and applying their standards and recommendations to improve organizational cybersecurity postures. * Strong knowledge of regulatory changes and trends impacting IT risk assessments, including compliance requirements such as GDPR, HIPAA, and others, ensuring risk management strategies align with the latest regulatory standards. * Knowledge of Operational Technology (OT) risk management is a plus, with the ability to assess risks related to OT environments and integrate them into overall IT risk strategies. * Minimum 3 years of experience evaluating technical design documents for systems or environments to assess associated risks, including reviewing architectural, infrastructure, and application designs for security and operational risk vulnerabilities. TECHNICAL EXPERTISE * Familiarity with GRC tools such as ServiceNow, LogicGate, or OneTrust * Strong understanding of technical infrastructure, including networks, cloud environments, endpoints, and medical device systems. * Experience with system integration and data flow analysis within GRC tools, ideally leveraging APIs and other automation technologies to improve operational efficiencies. CERTIFICATIONS * Certified Information Systems Security Professional (CISSP). * Certified in Risk and Information Systems Control (CRISC). * Certified Information Security Auditor (CISA). Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$104,000.00 - $156,000.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
    $104k-156k yearly Auto-Apply 2d ago
  • Senior Principal Automation Engineer (CVRM)

    Genentech 4.5company rating

    Los Angeles, CA job

    ** ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). **The Opportunity** A Senior Principal Automation Engineer is being hired to participate in Greenfield Project execution and then support the facility after going live. Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. Senior Principal Automation Engineer (Department: ITOT/Automation Engineering - Leadership Role) will be responsible for providing automation and instrumentation and controls engineering capabilities and experience to the ITOT / Automation Engineering Group including generating qualification protocols and maintaining the validated state of systems and processes. Initially, participates in Basic Design, Detailed Design and Facility Startup. Eventually focuses on providing long-term support for newly built facilities with respect to the automation and instrumentation and control systems for process, utility and building systems. Lead automation impacting projects with large and/or complex scope. Drive strategic initiatives to improve business processes. Be both a People Leader/ Coach and at times hands on SME. **What You'll Do** + Provide automation, instrumentation, and control engineering design services for facility projects, including upgrades, capacity expansions, and equipment replacements.. + Produce and review design drawings and specification documents (URS, FS, DS, etc.). + Support end-to-end system qualification, including test creation, execution, review and approval. + Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget. + Review and approve vendor information packages, including drawings and specifications as directed to ensure user requirements are met. + Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings. + Author and then Adhere to site SOPs and work instructions for daily and project deliverables. Drive improvements to business processes. + Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans). + Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines. + Automation lead for equipment/software FAT, field testing and commissioning + Provide scope, qualification, resource, and budget estimates for automation impacting projects. + Manage employees/ contractor staff, track project deliverables, and provide status updates to the project team. + Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices. + Provide input into network/global business processes and procedures (e.g. GSPs). + All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA). + Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt. + Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting. **Who You Are** + Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 8 years experience, or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 7years experience. + Minimum of 8 years applicable automation and/or instrument and control system experience preferably majority in drug product function + 5 years in the pharmaceutical/biotech industry/GMP experience. + 24X7 on call support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required. Knowledge, Skills and Abilities + Experience with Biopharmaceutical manufacturing, design or/and construction. + Knowledge of Industrial Ethernet networks for manufacturing. + Knowledge of vision systems + Knowledge of Drug Product Manufacturing processes including aseptic or robotic fillings systems, vial handling, environmental monitoring and clean utilities. + Knowledge of communication protocols for devices (OPC, Modbus, MQTT, Ethernet IO, IOT) + Knowledge of integration and data transfer with Level 2, 3, and 4 systems. + Qualification experience related to control and computer systems. + Ability to generate engineering drawings and specifications. + Knowledge of ISA standards and practices for instrumentation. + Knowledge of PID control theories and techniques. + Knowledge of programmable logic controllers, and associated programming languages (RS Logix Preferred). + Practical knowledge of process automation systems, and associated programming languages (Rockwell and Siemens preferred). + Demonstrate strong organizational, communication, and interpersonal skills to effectively manage tasks and collaborate with diverse teams. + Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility. + Demonstrate strong working knowledge of PC based programs and web based systems. + Ability to work independently with no direct supervision. + Knowledge of GAMP5 + Work in a standard office environment. + May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots. No make-up or jewelry can be worn when working in the clean room environment. + May work with hazardous materials and chemicals. **Relocation funding is available for this role.** The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $114,400 - $212,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (**************************************************** Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $114.4k-212.4k yearly 60d+ ago
  • Production/Chemical Dispensary Supervisor

    Bio-Rad Laboratories 4.7company rating

    Irvine, CA job

    Bio-Rad is looking for a Production Chemical Dispensary Supervisor to supervise the Lineside/Warehousing Department and oversee a production team that distributes chemical raw materials used to produce liquid reagent products. This position plans and assigns work to direct labor personnel, implements policies and procedures, and recommends improvements in production methods, equipment, operating procedures and working conditions within established delivery, quality, compliance, safety, budget and cost standards. How You'll Make An Impact: * Manages a team of production associates engaged in receiving, staging, put away, cycle count, and scrapping of production chemical inventory. * Work is monitored by the production manager. * Supervises team according to established processes, techniques and policies. * Schedules, assigns and manages the daily activities of a team. * Monitors employee performance and prepares and communicates performance reviews. * Coaches and trains personnel in their duties. * Assists in the development of documentation procedures. * Responsible for meeting key metrics such as production schedules, quality standards, production yields, cost targets. * Monitors processes and makes adjustment to stay within schedule, budgets and established targets. * Participate in a variety of standing meetings. * Communicate priorities, performance results and objectives to team members. * Troubleshoots production issues and escalates as appropriate. * Participate on project teams as needed. * Participate as the Bio-Rad representative for this department before FDA, DEA, CALOSHA, and other regulatory body audits. * Make salary recommendations based upon individual performance. * Interviews and select personnel. What You Bring: * High school diploma, GED or equivalent. * Associate's degree or equivalent experience preferred. * 3-5 years warehousing/logistics experience in a laboratory, instrument or chemical processing environment. * 0-2 years production lead experience is a plus. * Familiarity with assigned products. * Proven analytical, communication, computer and some project management experience. * Basic knowledge of inventory management, demand flow technology, production processes and related technologies. * Relevant certifications or training a plus. * Basic knowledge of regulatory requirements. Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle. Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more! Compensation: The estimated base salary range for this position is $68,640 - $92,900 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is also eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance. Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply. Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-KD2 Legal Entity: (USA_1000) Bio-Rad Laboratories, Inc.
    $68.6k-92.9k yearly Auto-Apply 37d ago
  • Group Product Manager, Downstream Marketing

    Edwards Lifesciences 4.6company rating

    Irvine, CA job

    Innovation starts from the heart. Heart valve disease and critical care therapies impact millions of lives, spanning all ages and geographies. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. Beyond raising awareness, our Marketing teams build lasting, trusted relationships with medical professionals and industry stakeholders to ensure patients can receive the treatments they need. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. The U.S. marketing team is seeking an experienced product marketer with an interest for field marketing and enhancing the customer experience to drive our mission forward in helping patients live longer and healthier lives. How you'll make an impact: • Develop and lead in the execution of comprehensive marketing plans including strategies and tactics for multiple products or programs and initiatives • Build relationships with the field team and key opinion leaders (KOL) to help inform customer engagement plans and understand current market environment and competition • Collaborate on marketing messages based on regional strategies, knowledge of current literature, current competitive environment, and regulatory/legal requirements for multiple products or programs and initiatives • Deep expertise and ownership over your respective product(s) or programs and initatives to the field team and customers, including traveling to sites about 30% of your time • Develop programs that support the field and commercialization strategies for multiple major initiatives, including collaboration with agencies to deliver assets across traditional, events and digital. • Lead content and delivery for aspects of the congress and event delivery process in the U.S. • Drive marketing collateral/labeling through all relevant legal and regulatory approval processes through collaboration with relevant cross-functional stakeholders for multiple major product launches or programs and initiatives • Forecast product and demo needs across the field team, internally and with partner teams to ensure proper allocation of respective products • Lead the execution of a multiple major programs and initiatives in collaboration with regional partners as appropriate including Salesforce readiness (e.g., training on product, messaging, and competition) • Build a deep understanding for the body of clinical and economic evidence that supports the regional value proposition • Manage budgets related to product line, campaigns and projects • Analyze clinical and market data to assess regional impact of potential product launches • Lead significant process or corporate initiatives that impact and bring value to the marketing organization • Represent product needs, updates, milestones and planning to all levels of the organization and range of functions, from leadership to sales and commercial excellence to global peers • Other Incidental Duties What you'll need (Required): • Bachelor's Degree in related field with 8 years of experience or • Master's Degree or equivalent in a related field with 6 years of experience working in sales, marketing, or healthcare industry Required What else we look for (Preferred): • Strict attention to detail. • Excellent documentation and communication skills and interpersonal relationship skills. • Expert understanding of related aspects of marketing concepts and principles, including application to the field team and commercial excellence team. • Proven successful project management skills. • Proven expertise in Microsoft Office Suite. • Experience with product marketing and product management across more than one product or product line • Extensive understanding of broad market research designs, develops market research programs coordinating with the global VOC manager and demonstrates an in-depth understanding of commercial goals behind research. • Ability to forecast product lines for short-term and long-term accuracy based on market development, sales trends, competition and changing market dynamics. • Possess strong clinical knowledge, experience and knowledge of the clinical areas where Edwards' products are used or intended to be used, understand the purchasing process and challenges for product adoption in complex healthcare networks. • Ability to manage competing priorities in a fast paced environment. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA) the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $142k-201k yearly Auto-Apply 8d ago
  • Senior Principal IT/OT Infrastructure Engineer (CVRM)

    Genentech 4.5company rating

    Los Angeles, CA job

    ** ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). **The Opportunity** A Senior Principal ITOT Infrastructure Engineer is being hired to participate in Greenfield Project execution and then support the facility after going live. Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. **What You'll Do** Senior Principal ITOT Infrastructure Engineer (Department: ITOT/Infrastructure - Leadership Role) will be Responsible for providing IT Infrastructure engineering capabilities and experience to the ITOT Group including generating qualification protocols and maintaining the validated state of systems and processes. Initially, participates in Basic Design, Detailed Design and Facility Startup focussed on data center and filed IT infrastructure. Eventually focuses on providing long-term support for newly built facilities with respect to the Infrastructure for process, utility and building systems. Lead Infrastructure impacting projects with large and/or complex scope. Drive strategic initiatives to improve business processes. Be both a People Leader/ Coach and at times hands on SME. Act as Cyber Security Coordinator / Engineer. Provide basic IT support for Site workplace needs in collaboration with Global IT groups. + Site Owner of "OT Infrastructure" for Manufacturing System Platforms including Syncade MES, DeltaV Distributed Control System, PLC's, Lab Data Systems (Smartline Data Cockpit) + Site Lead for Global Cyber Security Initiatives + Site OT Infrastructure Support Lead and Coordinator with Global Infrastructure solutions at site (e.g. support of AD and firewall policies to allow proper access and communication from either AD security or network firewall policies, and commissioning and startup support) + May eventually expand role to become Regional OT Infrastructure Lead for multiple sites supporting ITOT operating model evolution + Collaborate with IT Engineers and Architects, Automation Engineers + Lead and/or provide support for the evaluation, installation, and maintenance of Manufacturing infrastructure including installation and upgrade of control systems hardware, software, control networks, user administration, database administration, security, system monitoring, backup and recovery of Microsoft Windows Server Operating Systems and SQL Databases + Lead and/or support implementation of OT infrastructure standards and best practices across all Site OT and Process Automation platforms, working with other process automation engineers, IT and OT professionals. + Support commissioning and startup activity of new process control systems and manufacturing systems (Syncade, DeltaV, PLC's, OSI PI historian, etc). + Be the go to Infrastructure expert at the site who bridges the gap between Automation and underlying Storage Compute and Network infrastructure + Execute control system virtualization administration, user administration, system monitoring, capacity planning, design, installation, configuration, and upgrade of platform. + Execute computer system validation and control system lifecycle management. + Produce and review design drawings and specification documents (URS, FS, DS, etc.). + Support end-to-end system qualification, including test creation, execution, review and approval. + Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget. + Review and approve vendor information packages, including drawings and specifications as directed to ensure user requirements are met. + Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings. + Author and then Adhere to site SOPs and work instructions for daily and project deliverables. Drive improvements to business processes. + Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans). + Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines. + Automation lead for equipment/software FAT, field testing and commissioning + Provide scope, qualification, resource, and budget estimates for automation impacting projects. + Manage employees/ contractor staff, track project deliverables, and provide status updates to the project team. + Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices. + Provide input into network/global business processes and procedures (e.g. GSPs). + All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA). + Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt. + Support work of the Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting. **Who You Are** + Bachelor's degree in Engineering, Computer Science, or equivalent experience. + A minimum of 5 years systems engineer experience involved in the design, implementation, and/or support of automation systems, preferably in a regulated (Pharmaceutical) industry. + 24X7 support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required. + Experience with Operating Systems, Virtualization, LAN/WAN, Firewalls, SQL Servers client-server and terminal virtualization as a System Administrator + Certifications: Certified Information System Security Professional (CISSP), ISA/IEC 62443 Cybersecurity Specialist certification, Global Industrial Cyber Security Professional (GICSP) is a plus Knowledge, Skills and Abilities + Experience with Biopharmaceutical manufacturing, design or/and construction. + Knowledge of Industrial Ethernet networks for manufacturing. + Knowledge of vision systems + Knowledge of Drug Product Manufacturing processes including aseptic or robotic fillings systems, vial handling, environmental monitoring and clean utilities. + Knowledge of communication protocols for devices (OPC, Modbus, MQTT, Ethernet IO, IOT) + Knowledge of integration and data transfer with Level 2, 3, and 4 systems. + Qualification experience related to control and computer systems. + Ability to generate engineering drawings and specifications. + Demonstrate strong organizational, communication, and interpersonal skills to effectively manage tasks and collaborate with diverse teams. + Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility. + Demonstrate strong working knowledge of PC based programs and web based systems. + Ability to work independently with no direct supervision. + Knowledge of GAMP5 + Work in a standard office environment. + May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots. No make-up or jewelry can be worn when working in the clean room environment. + May work with hazardous materials and chemicals. **Relocation funding is available for this role.** The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $114,400 - $212,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (**************************************************** Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
    $114.4k-212.4k yearly 60d+ ago
  • Software Project Manager

    PSC Biotech 3.9company rating

    PSC Biotech job in Thousand Oaks, CA

    PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi -cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role We are seeking a skilled and proactive Project Manager to lead the successful implementation of software solutions across the organization. This role involves managing project timelines, coordinating cross -functional teams, and ensuring that software deployments meet business requirements, quality standards, and deadlines. Lead end -to -end software implementation projects, from planning through deployment and post -launch support. Develop detailed project plans, including scope, schedule, budget, resources, and risk management strategies. Collaborate with internal stakeholders, vendors, and technical teams to define project requirements and deliverables. Monitor project progress and adjust plans as needed to ensure timely delivery. Facilitate regular status meetings, provide updates to leadership, and manage stakeholder expectations. Identify and mitigate project risks and issues proactively. Ensure proper documentation, training, and change management processes are in place. Evaluate project outcomes and conduct post -implementation reviews to identify areas for improvement. Requirements Bachelor's degree in computer science, Information Systems, Business, or related field. 3-5 years of experience managing software implementation projects. Strong understanding of project management methodologies (Agile, Waterfall, Hybrid). Experience with enterprise software systems (e.g., ERP, CRM, HRIS). Excellent communication, leadership, and organizational skills. Proficiency in project management tools (e.g., MS Project, Jira, Asana). PMP, Scrum Master, or similar certification is a plus. Benefits Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 to $110,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer -sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI -RT1
    $90k-110k yearly 60d+ ago
  • Manager, Business Solutions THV

    Edwards Lifesciences 4.6company rating

    Los Angeles, CA job

    Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Aortic stenosis & aortic regurgitation impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. **How you will make an impact:** + Oversee the reengineering and optimization of business processes and systems using Power Platform. Act as a Power Platform Subject Matter Expert and be seen as a Power Platform specialist + Configure and test Power Platform systems (Power Apps, Power Automate) to execute features, integration, and reporting + Evaluate and validate functional business requirements against business needs. Translate the needs of the business into Power Platform and Dataverse solutions + Identify root causes and provide guidance for resolutions for testing and validation of Power Platform processes and systems + Serve as liaison between team members and stakeholders in the area of responsibility. Lead efforts to reengineer and optimize business processes and systems + Provide design and architecture guidance to project teams to execute tactical projects / initiatives + Provide leadership and guidance to business CRM administrators on best practices + Provide platform guidance to team members on CRM and Power Platform solutions + Identify and recommend innovations that significantly enhance efficiency and effectiveness of business processes **What you will need (Required):** + Bachelor's Degree & a minimum of 8 years of experience in a digital Project Management, Product Management or Customer Success role OR equivalent related experience based on Edwards criteria + A minimum of 3 years hands-on experience with Power Apps (Canvas and Model-driven applications) + A minimum of 3 years experience with Power Automate (Cloud flows, Desktop flows, Business process flows) + A minimum of 2 years experience with Microsoft Dataverse (data modeling, security, business rules) **What else we look for (Preferred):** + Stay current with latest platform features + Microsoft Power Platform certifications (PL-200, PL-400 preferred) + Proven successful project management skills + Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards + Extensive knowledge in at least discipline (e.g. Power Platform ALM and solution management) + Substantial technical knowledge with expertise in at least one technical language or data management system (e.g. Knowledge of Power BI for embedded analytics within Power Apps) + Extensive knowledge of platform ecosystem and integration points within Power Platform and governance + Represents leadership on sections of projects within a specific area interfacing with project managers and team. Ability to train and mentor team members on Power Platform best practices + Consult in project setting within specific sections of area (Experience integrating Power Platform with Azure services and Microsoft 365) Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $118,000 - $167,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. \#LI-Hybrid Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $118k-167k yearly 45d ago
  • Director of Product Marketing

    Edwards Lifesciences Corp 4.6company rating

    Irvine, CA job

    Innovation starts from the heart. Heart valve disease impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more crucial than ever. Beyond raising awareness, our Marketing teams build lasting, trusted relationships with medical professionals and industry stakeholders to ensure patients can receive the treatments they need. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make a difference: * Develop and lead in the execution of comprehensive launch plans including strategies and tactics for multiple major/high value products launches, programs, and initiatives * Build relationships with key opinion leaders (KOL) to help inform product launch plans and understand current market environment and competition * Develop marketing messages based on regional strategies, knowledge of current literature, current competitive environment, and regulatory/legal requirements for multiple major/high value products launches, programs, and initiatives * Develop product materials and programs that support product launch and commercialization strategies for multiple major/high value products launches, programs, and initiatives * Lead major projects for the Congress Management process * Drive marketing collateral/labeling through all relevant legal and regulatory approval processes through collaboration with relevant cross-functional stakeholders for multiple major/high value products launches, programs, and initiatives * Develop product usage and patient brochures required for regional product approvals for multiple major/high value products launches * Lead the execution of a multiple major/high value products launches, programs, and initiatives in collaboration with regional partners as appropriate including Salesforce readiness (e.g., training on product, messaging, and competition) * Define and build a body of clinical and economic evidence that supports the regional value proposition * Manage budgets related to product line, campaigns and projects * Analyze clinical and market data to assess regional impact of potential product launches * Lead significant process or corporate initiatives that impact and bring value to the marketing organization * Other Incidental Duties13. Other incidental duties What you'll need (Required): Bachelor's Degree 12 years of experience of work experience Master's Degree or equivalent with 10 years of experience of related experience working in sales, marketing, or healthcare industry What else we look for (Preferred): * Proven successful project management skills * Proven expertise in Microsoft Office Suite * Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives * Recognized as an expert in one or more areas with broad-based advanced knowledge within the organization * Expert understanding of related aspects of marketing concepts and principles * Extensive understanding of broad market research designs, develops market research programs coordinating with the global VOC manager and demonstrates an in-depth understanding of commercial goals behind research. * Ability to forecast product lines for short-term and long-term accuracy based on market development, sales trends, competition and changing market dynamics. * Ability to assess and understand market share, pricing, ASPs, competitive dynamics * Possess strong clinical knowledge, experience and knowledge of the clinical areas where Edwards' products are used or intended to be used, understand the purchasing process and challenges for product adoption in complex healthcare networks * Strict attention to detail * Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization * Ability to manage competing priorities in a fast paced environment * Represents leadership on projects within multiple areas, working closely with cross-functional team, marketing peers and leaders and managing needs and messaging to upper management * Consult in project setting within multiple marketing areas, interfacing with low to middle management * Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $170,000 to $241,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $170k-241k yearly Auto-Apply 60d+ ago
  • CQV Engineer

    PSC Biotech 3.9company rating

    PSC Biotech job in Thousand Oaks, CA

    Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role We are hiring an experienced CQV engineer responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met. Develop and execute commissioning, qualification, and validation protocols for required systems and equipment (i.e process skids, chromatography skids). Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures. Identify and assess risks associated with CQV activities and develop effective mitigation strategies. Troubleshoot and resolve issues related to equipment and process performance. Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines. Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.). Additional responsibilities as required to drive successful validation project deliverables. Requirements Bachelor's degree in Engineering, Life Sciences, or a related field. 6-10 years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries. Strong knowledge of regulatory requirements and industry standards. Experience with validation lifecycle management and risk-based approaches. Excellent analytical and technical problem solving skills. Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.) Effective communication and interpersonal skills. Proactive with strong organization, time management, and project management abilities. Excellent attention to detail with commitment to quality and compliance. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments are essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. Must be authorized to work in the US. No C2C at this time BenefitsW2 Temp positions include our medical and sick time benefits Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $100,000 to $120,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LD-RD1
    $100k-120k yearly 23d ago
  • Validation Engineer

    PSC Biotech 3.9company rating

    PSC Biotech job in Irvine, CA

    PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi -cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role Our Validation Engineers support the full CQV lifecycle, ensuring facilities, utilities, equipment, computerized systems, and manufacturing processes are designed, installed, operated, and maintained in compliance with FDA, EU, and global GxP regulations. This role plays a critical part in reducing compliance risks and enhancing operational performance while executing high -quality validation deliverables, providing technical expertise, and supporting regulatory readiness. Responsible for the planning, commissioning, qualification, and validation activities for required cGMP manufacturing and lab equipment, utilities, and computerized systems. Author, review, and execute validation deliverables including but not limited to validation plans, design specifications, user requirement specifications, risk assessments, DQ, IQ, OQ, PQ generation and testing, summary and final reporting. Perform system readiness assessments and verification testing. Ensure systems meet user requirements, functional specifications, and data integrity expectations. Manage system implementation activities including configuration, backup/restore, and periodic reviews. Write, review, and approve SOPs; ensure documentation is accurate, traceable, audit -ready, and compliant. Participate in deviation investigations, root cause analysis, and support CAPA implementation and change control processes. Provide user training and ongoing technical support. Collaborate with cross -functional teams to align on technical functions, deliverables, and quality events. Additional responsibilities as required to drive project success. Requirements Bachelor's degree in engineering or related technical discipline. 3-10 years of experience in validation within GMP -regulated environments (pharmaceutical or biotech). Hands -on experience validating GxP manufacturing and lab based equipment, analytical instruments, and associated computerized systems. Strong understanding of full lifecycle validation and risk -based approach. Well -versed in regulatory requirements and guidelines (FDA, EMA, ICH, cGMP, GAMP 5, 21 CFR Part 11, EU Annex 11). Experienced with traceability, change control, deviation handling, and CAPA management. Strong technical writing and documentation skills. Excellent attention to detail, problem -solving, and analytical skills. Ability to manage multiple projects and timelines. Willingness to travel as needed for project assignments and client engagements. Must be authorized to work in the US. No C2C at this time. BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $75,000 - $125,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer -sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI -RD1
    $75k-125k yearly 29d ago

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