Lead Engineer jobs at Astellas Pharma

The Development and Commercialization Team (DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial product. The specific role will be responsible for advancing the company's biologics portfolio. Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the following areas: Responsible for on-time, end-to end execution of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to achieve uninterrupted long-term supply Lead DCT. Critically assesses all team deliverables & fosters a learning and collaborative environment. Prioritizes, interrogates and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen circumstances. Responsible to ensure the best science and most robust processes are used, working closely with DCRC. As the Product TPL takes ownership for the products' technical processes and associated technical challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors. Conducts options analysis and provides recommendation to governance for endorsement. Represent CMC and effectively communicates across the governance bodies, stakeholders and teams. Drives outcomes/decisions through influence, advocacy, & negotiation with stakeholders. Influences and challenges the product development team's strategy to ensure a robust CMC strategy is achieved. Identifies options to balance Speed/Cost/Robustness & achieve target commercial product. Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by working teams supporting the product. Compile with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture. Core Competencies: Development and Commercialization Experience: Demonstrated expertise of technical aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality, and Supply Chain from early development through to commercial manufacturing. Deep understanding of connectivity between clinical, CMC, and HH to successfully launch a new product. Technical Depth and Breadth of Experience: Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC function and ability to navigate through uncertainty to favorable outcomes. Strategic Thinking/Enterprise Mindset: Understands and can articulate the “Big” picture, thinks strategically, and demonstrates a customer orientation. Demonstrated ability to know how to ask the right questions to drive critical conversations to the best decision for the enterprise, considering options which balance speed, cost, and robustness. Challenges team members to think beyond their area of expertise for the broader interests of the company and patients we serve. Problem Solving and Innovative Thinking: Gathers and analyzes data and effectively responds to new or complex situations, developing creative and innovative solutions to solve and mitigate complex problems. Ability to leverage scientific expertise and growth mindset to interrogate data and foster debate within teams to enable innovative and robust problem solving. Ability to Navigate Ambiguity: Able to operate and provide direction through ambiguity and adapt plans in the face of change, unexpected events, and/or new information. Capable of both directive and consensus facilitation and awareness of when to apply each. Leverages scientific data to make disciplined risk-based decisions and shown to be capable of discerning between risks worthy of escalation versus typical uncertainty associated with drug development, commercialization, and/or supply. Productive Communication: Plans and delivers ideas and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of the enterprise. Capable of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse backgrounds. Practitioner of active listening who consistently strives to understands others' perspectives, concerns, and ideas. Collaboration and Teamwork: Creates, leads, and sustains high performing teams, fostering an environment of open communication, enabling all team members to contribute their perspectives and collectively resolve issues. Actively builds strong relationships with team members and key stakeholders to promote collaboration and seek robust perspectives. Drives Results through Accountability: Demonstrates effective leadership of team activities to ensure on-time, end-to-end project execution and delivery. Drives accountability within teams to follow through on commitments, provides direct feedback when individuals are not meeting expectations, and closely partners with senior leaders to deliver on priorities. Influence: Ability to persuade and inspire others to take action, make decisions, or change their attitudes and behaviors. Rapidly able to achieve trust with partners, enabling ability to navigate complex organizational dynamics to achieve their goals. Ownership: Exhibits a proactive mindset, a strong sense of initiative, and the willingness to take on challenges and see them through to completion. Fostering a culture of accountability and resiliency within the team or organization and empowering others to take ownership of their roles and responsibilities. Minimum Educational Requirement and Experience: Bachelor of Science (BS) Degree in relevant engineering or science fields with fifteen (15) years of relevant experience, or Master of Science (MS) Degree with twelve (12) years of relevant experience, or PhD with ten (10) years relevant experience Required Experience and Skills: Strong cross divisional networking skills and capabilities Demonstrated functional and enterprise leadership, ability to influence at all levels of the organization. Strong collaborative skills and the ability to work strategically and in a detail-oriented framework with all levels of management. Must have strong understanding of product management systems and tools, strong business and financial skills, ability to manage multiple programs and create a high-performance work environment Preferred Experience and Skills: Experience in ADC development and commercialization. Experience in Technical product stewardship Demonstrated track record of successfully commercializing multiple large molecule programs across a variety of platforms Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly Expert knowledge in QbD Required Skills: Accountability, Accountability, Active Listening, Applied Engineering, Capital Management, Change Management, Chemical Process Development, Commercialization, Communication Strategy Development, Corporate Productions, Cost Management, Cross-Cultural Awareness, Cross-Functional Leadership, Cross-Functional Teamwork, Decision Making, Drug Development, External Manufacturing, GMP Compliance, Innovation, Leadership, Life Science, Management Process, Manufacturing Scale-Up, Mitigated Risks, Options Analysis {+ 14 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/2/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Contract Duration: 12+ Months, Potential to go longer Role will drive the CQV strategy for the project, leading a team of engineers to successfully deliver deliverables Author, edit, and execute technical commissioning, qualification and validation documentation for standard equipment/systems/ software Adherence with project schedule for all assigned activities Maintaining clear, detailed records for qualification and validation Documenting impact and risk assessments as part of a team Making recommendations for design or process modification based on test results when executing test scripts General understanding of capital equipment implementation and process knowledge Understanding validation documentation from URS to Summary Reporting Requirements Must be willing to work onsite in Syracuse, NY Minimum of 12 years of experience in CQV activities specific to a broad range of facility, utility, and process equipment including autoclaves, fillers, reactors, isolators, freezers, etc. Extensive experience authoring and executing IQ/OQ/PQ activities Ability to write sampling protocols and develop protocol templates Specific qualification experience with Autoclaves, TFF Skid, chrome skid (preferred) Experience qualifying Single User Reactors and Single Use Mixers (preferred) Experience developing and executing mixing studies Experience with clean room developing and/or executing EMPQ protocols Knowledge of Process Automation and equipment testing Experience using Delta V Bachelor's degree (minimum) in hard sciences, preferably Chemical Engineering Proficiency in using PC and Microsoft Office tools Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms Ability to lead a team of engineers Strong problem-solving and critical thinking skills Excellent organizational and time management skills Strong attention to detail GMP and Good Documentation Practice knowledge Strong interpersonal skills and clear communication capabilities Experience with and tolerance for high levels of challenge and change Proven attention to detail and organization in project work Capable of working on assigned tasks without mentorship

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care, and as such will become a part of the BD organization in the future. Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com Provides expertise in the optimization of product development. How you will make an impact: Design and develop components and systems utilizing SolidWorks design tools while applying mechanical engineering principals. Lead in the improvement, design and optimization of more complex experiments, tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work. Proactively identify issues, achieve resolution, and resolve problems of significant complexity on designing parts, components and subsystems Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications Create/update complex design control documents including requirement specs, and risk documents with robust knowledge on design control requirements Develop project plans to assess technology and drive project results Train, coach, and guide lower-level employees on more complex procedures What you'll need (Required): Bachelor's Degree in Mechanical Engineering with a minimum of 8 years' experience including either industry or industry/education or Master's Degree or equivalent in in Engineering or Scientific field with a minimum of 6 years' experience, including either industry or industry/education Required or What else we look for (Preferred): Experience with Ansys and or Icepak FEA tools Excellent documentation and communication skills Excellent interpersonal relationship skills including negotiating and relationship management skills Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering Advanced problem-solving, organizational, analytical and critical thinking skills Extensive understanding of processes and equipment used in assigned work Ability to influence others Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts Represents organization in providing solutions to difficult technical issues associated with specific projects 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 At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - Irvine Laguna CanyonAdditional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $124,700.00 - $205,800.00 USD Annual

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Lead Analytics Engineer The individual must be able to articulate complex technical topics, collaborate with internal and external partners, and ensure quality delivery of the required data products. Reporting to the Associate Director - Data Platforms, the Lead Analytics Engineer is responsible for making our data accessible, understanding its business value, generating insights, and communicating those insights effectively to deliver value and enable decisions. This role focuses on speed to insight, raising our organization's data fluency, and championing continual improvement. Your Responsibilities: * Lead the design and implementation of scalable data modeling frameworks that transform raw data into reliable, analytics-ready datasets. * Establish organizational standards for metric definitions, business logic, and data transformation patterns. * Address enhancements, requests, and incidents related to our enterprise visualizations and Power Platform landscape. * Influence Data Platforms product owners and leadership to ensure the appropriate prioritization and planning of opportunities occurs. * Mentor analysts and analytics engineers on data modelling, SQL best practices, and analytics engineering principles. * Continuously educate stakeholders about services, standards, examples, and patterns provided by the Data Platforms team. * Work with the Product manager and Operations Lead to ensure related service offerings are represented appropriately in the catalog and are accessible/discoverable by stakeholders. * Represent the Data Platforms team across Elanco as a data evangelist and champion in our various communities, forums, and working groups. What You Need to Succeed (minimum qualifications): * Bachelor's degree in computer science, Data Analytics or equivalent professional experience. * 8+ years of analytics/BI experience, with 3+ years focusing on analytics engineering * Expertise in dimensional modeling and metrics/semantic layer design What will give you a competitive edge (preferred qualifications): * Expertise in data testing and validation frameworks. * Demonstrated experience leveraging analysis, visualization, and communication skills to create artifacts resulting in actionable insights. * Experience mentoring analysts in SQL and data modeling best practices. * Understanding of data governance and metadata management. * Demonstrated experience with the relevant languages, tools and technologies associated with modern data analysis with an emphasis on Power BI/Power Platform, Tableau, Databricks, the Azure Platform, SQL, Power Query and DAX * Prototyping experience using Figma Additional Information: * Travel: 0% * Location: India, Bangalore Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Lead Software Engineer At Elanco, our engineer roles bring adaptive set of skills covering Software-as-a-Service (SaaS), Commercial-of-the-Shelf (CotS) and/or Custom Developed applications. The role is part of our software engineering team established to deliver Engineering expertise to business facing products and services. As an Engineer you will be deployed into a multi-disciplined product team applying your software engineering talent to Elanco's biggest opportunities. Your Responsibilities: * Join a diverse engineering organization and contribute to growing our engineering capabilities across Software, and Platform Engineering. * Develop full-stack solutions, building highly scalable distributed solutions that enable positive user experiences and measurable business growth. * Implement and support modern digital products that are technologically sound, avoid technical debt, guarantee compliance, and enable the required business outcome. * You will contribute and shape our Horizon software developer patterns leveraging infrastructure as code and providing opinionated view that gets developers across the enterprise started faster. * You will define the testing strategy for projects, including various types of testing. Implements automated testing frameworks * You will assess the risks early in the product discovery process, considering factors like time constraints, available skills and technologies, and potential technical debt. Ensuring the team builds only what is truly valuable * Use modern product approaches to influence and shape the business through partnership with product management and digital product delivery utilizing modern product approaches such as rapid prototyping and embedding a 'show them, don't tell them'Culture. What You Need to Succeed (minimum qualifications: * Education Requirements: Bachelor's Degree in Information Technology or Computer Science. * 10 + years of experience working with modern application architecture methodologies * 5 + years of experience working with Cloud Native design patterns, with a preference towards Microsoft Azure / Google Cloud. * 8 + years of experience designing and delivering digital solutions following a product-mindset and a variety of delivery methodologies (e.g. Agile, CCPM, etc.). * 5 + years of experience working within a "DevSecOps" culture, including modern software development practices, covering Continuous Integration and Continuous Delivery (CI/CD), Test-Driven Development (TDD), etc. * Familiarity or experience with Infrastructure as Code (IaC) (e.g., Terraform). * Experience with software deployment capabilities including Kubernetes. * Experience in a Platform Engineering team beneficial. * Operational experience having supported and iterated on custom built applications * Proficiency in TypeScript/JavaScript, React, and Node.js. * Passion for simplicity and great Developer Experience. * Experience scaling an "API-Ecosystem", designing, and implementing "API-First" integration patterns. What will give you a competitive edge (preferred qualifications): * Experience defining and implementing large-scale, transformative digital solutions. * Experience working in complex, diverse landscapes (business, technology, regulatory, partners, providers, geographies, etc.). * Experience with software deployment capabilities including Kubernetes. * Experience in a Platform Engineering team beneficial. Additional Information: * Travel: 0% * Location: India, Bangalore Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

About Krystal Bio: At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic diseases. Founded in 2016, Krystal is a leader in gene therapy. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEK, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline. Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities. Additional offices are situated in Boston, MA and in Zug, Switzerland. Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patients! Job Description Summary: Krystal Biotech, Inc is seeking a highly motivated and dynamic Bioprocess Engineer to support our product manufacturing at our Pittsburgh GMP facility. This role is critical to our make a meaningful difference in the lives of underserved patient populations having rare diseases. Quality, safety and on-time delivery is a must to be successful in this role! The ideal candidate will have foundational experience in upstream and/or downstream biologics or gene therapy manufacturing. Primary Responsibilities: * Perform/support/monitor the process steps/activities - buffer preparation, upstream, downstream, Aseptic Fill * Document/record data following standard operating procedures or GMP documents for process steps and/or equipment activities * Maintain equipment and operate - facilitate/perform qualifications, cleaning, logbooks * Clean, maintain, and monitor the GMP facility * Collaborate with Quality assurance, Quality control, Facilities, Materials and others * Participate in learning and training to be competent in above functions * Other duties as assigned Requirements and Preferred Qualifications: * Bachelor's degree, preferably in life sciences * Expertise working in a clean room facility, 1+ years of professional experience demonstrating proper cleanroom behavior/technique * Cell culturing / Aseptic technique * Familiarity with large scale bioreactors highly preferred * Downstream processing experience * Filtration/Purification * Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking * Highly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure * A demonstrated understanding of the drug development process, biopharmaceutical industry and/or related life sciences industry * Demonstrated ability to prioritize and manage multiple projects simultaneously * Demonstrated ability to work effectively with many different types of personalities at all levels of the organization * Excellent interpersonal, collaboration and stakeholder management skills * Excellent communication skills (written/verbal) Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.

Red Rock Government Services is a leading software engineering company recognized for its exceptional support to the intelligence community. With a proven track record of delivering innovative and mission-critical solutions, Red Rock specializes in developing secure, scalable, and cutting-edge technologies tailored to meet the complex needs of intelligence operations. The company's expertise in advanced analytics, cloud computing, and artificial intelligence enables it to empower agencies with enhanced decision-making capabilities and operational efficiency. Red Rock's commitment to excellence, agility, and collaboration solidifies its reputation as a trusted partner in safeguarding national security and advancing intelligence objectives. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. RedRock is currently seeking a seasoned Lead BERT AI & Elasticsearch Integration Specialist (AI/Software Engineer - SME) to steer the integration of BERT AI tools and Elasticsearch into our AWS cloud environment. This pivotal role is instrumental in bridging the gap between stakeholder expectations and development realities, ensuring the seamless deployment and functionality of our machine learning and AI frameworks on the cloud. Key Responsibilities: Spearhead the integration of BERT AI tools into our AWS cloud infrastructure, ensuring the robustness and effectiveness of the deployed solutions. Liaise with stakeholders to gather requirements, set integration goals, and communicate progress, challenges, and outcomes. Engage with the development team, providing guidance, support, and direction throughout the integration process. Get hands-on with AWS cloud technologies, API construction, and search technologies, ensuring optimal performance and alignment with organizational objectives. Conduct technical reviews, ensuring all integration steps adhere to best practices and standards. Facilitate knowledge transfer sessions, up skilling the team on BERT AI tools and AWS cloud technologies. Requirements: Bachelor's degree in computer science, Engineering, or related field. Proficient in AWS cloud technologies, with a strong grasp of API construction and search technologies. Prior experience with BERT AI tools and machine learning platforms is highly desirable. Experience with large text datasets as well as creating synthetic data files is preferred Demonstrated leadership experience, ideally in a cloud integration or development lead role. Ability to work independently with excellent communication and stakeholder engagement skills. Strong and proactive problem-solving and analytical abilities. Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law.

Red Rock Government Services - Discover a company you'll love to work for... Red Rock Government Services is a Woman-owned Small Business consultancy providing strategic, IT, financial, and management consulting services to the federal government within the national security environment. We are mission-focused in creating value for our customers and people-focused in providing fulfilling career and growth opportunities for our employees. We offer a generous compensation package with employee incentives, above industry-standard benefits, and a strong focus on work-life balance. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. RedRock is actively seeking a proficient Software Developer specializing in independent work within a dynamic Agile scrum software development environment. The ideal candidate will possess extensive experience in utilizing agile development tools and methodologies to foster collaboration within Agile team frameworks. Required Skills: Proficiency in developing and maintaining applications using: Angular Node.js JavaScript Bootstrap or Material Design Browser technologies (HTML, HTTP, CSS) Elasticsearch ELK stack AWS (desired) MongoDB (desired) Cypress (desired) Experience with key tools and platforms: JIRA for maintaining stories and tasks. Confluence for collaboration Unit testing methodologies GitHub for version control Jenkins (desired) for automation Familiarity with: DevOps practices, build automation, and continuous integration (desired) Strong skills in: Participating in daily stand-ups Engaging in technical discussions, forums, and retrospectives Contributing to routine customer meetings and ad hoc sessions Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law.

Red Rock Government Services is a leading software engineering company recognized for its exceptional support to the intelligence community. With a proven track record of delivering innovative and mission-critical solutions, Red Rock specializes in developing secure, scalable, and cutting-edge technologies tailored to meet the complex needs of intelligence operations. The company's expertise in advanced analytics, cloud computing, and artificial intelligence enables it to empower agencies with enhanced decision-making capabilities and operational efficiency. Red Rock's commitment to excellence, agility, and collaboration solidifies its reputation as a trusted partner in safeguarding national security and advancing intelligence objectives. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. RedRock is currently seeking a DevOps Software Engineer to join our team of diverse and qualified professionals. In this role, you will play a key part in advancing our mission of delivering cutting-edge language training to ensure proficiency across a wide range of languages for the Sponsor's employees. DevOps Software Engineers contribute to the development of state-of-the-art IT solutions, working closely with cross-functional teams and sharing valuable insights and lessons learned. The role emphasizes facilitating container deployments and implementing serverless architectures within AWS. We value versatility and enthusiasm in tackling new challenges. At RedRock, we believe that hiring exceptional talent and fostering diversity of perspectives, ideas, and cultures are essential to creating superior products. Requirements: BS/BA in Computer Science OR equivalent combination of education and experience Object Oriented Programming experience. Experience with AWS (e.g., CloudFormation, EC2, Lambda, DynamoDB, and ElasticSearch) Experience with relational databases (e.g., RDS, Oracle, Postgres) Experience in continuous integration technology (e.g., Chef, Puppet, Docker, Jenkins, Ansible) Experience with interacting in a Linux environment (ex - Bash scripting) Desired Qualifications: Experience with Java, JavaScript, Python, Ruby Experience with application platforms such as Spring Boot or Angular Experience with log analytics tools such as Splunk or ElasticSearch Experience working with containers using Docker. Experience with container orchestration systems such as Kubernetes and Mesos Experience in communicating with users, technical teams, and senior management. Comfortable working in a fast-paced environment Comfortable managing competing priorities and are able to bring order to ambiguous scenarios. Familiarity with Source code management and integration (ex - GitHub/GitLab) Experience in an Agile environment (JIRA, Confluence) Location: Chantilly, VA Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. VA Red Rock is an Equal Opportunity Employer. We are always searching for strong technical talent to help us serve our DoD and IC customers around the Washington, DC metro area. We are constantly in need of developers, designers, architects, engineers, QA/testers, cyber security specialists and more . CJ123

Red Rock Government Services - Discover a company you'll love to work for... Red Rock Government Services is a Woman-owned Small Business consultancy providing strategic, IT, financial, and management consulting services to the federal government within the national security environment. We are mission-focused in creating value for our customers and people-focused in providing fulfilling career and growth opportunities for our employees. We offer a generous compensation package with employee incentives, above industry-standard benefits, and a strong focus on work-life balance. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. At Red Rock, our DevOps Software Engineers champion state-of-the-art IT solutions by collaborating closely with cross-functional teams and actively sharing knowledge gained. We specialize in facilitating container deployments and implementing serverless architectures within AWS. We value versatility and enthusiasm in our DevOps Software Engineers, encouraging them to tackle new challenges with vigor. We strongly believe that fostering diversity of perspectives, ideas, and cultures is integral to our success in creating superior products. By embracing varied backgrounds and insights, we enhance innovation and achieve excellence in our endeavors. Required Qualifications: Object Oriented Programming experience. Experience with AWS (e.g., CloudFormation, EC2, Lambda, DynamoDB, and ElasticSearch) Experience with relational databases (e.g., RDS, Oracle, Postgres) Experience in continuous integration technology (e.g., Chef, Puppet, Docker, Jenkins, Ansible) Experience with interacting in a Linux environment (ex - Bash scripting BS/BA in Computer Science OR equivalent combination of education and experience Desired Qualifications: Experience with Java, JavaScript, Python, Ruby Experience with application platforms such as Spring Boot or Angular Experience with log analytics tools such as Splunk or ElasticSearch. Experience working with containers using Docker. Experience with container orchestration systems such as Kubernetes and Mesos Experience in communicating with users, technical teams, and senior management. Comfortable working in a fast-paced environment Comfortable managing competing priorities and are able to bring order to ambiguous scenarios. Familiarity with Source code management and integration (ex - GitHub/GitLab) Experience in an Agile environment (JIRA, Confluence) Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. VA Red Rock is an Equal Opportunity Employer. We are always searching for strong technical talent to help us serve our DoD and IC customers around the Washington, DC metro area. We are constantly in need of developers, designers, architects, engineers, QA/testers, cyber security specialists and more . CJ123

Job Description Red Rock Government Services - Discover a company you'll love to work for... Red Rock Government Services is a Woman-owned Small Business consultancy providing strategic, IT, financial, and management consulting services to the federal government within the national security environment. We are mission-focused in creating value for our customers and people-focused in providing fulfilling career and growth opportunities for our employees. We offer a generous compensation package with employee incentives, above industry-standard benefits, and a strong focus on work-life balance. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. At Red Rock, our DevOps Software Engineers champion state-of-the-art IT solutions by collaborating closely with cross-functional teams and actively sharing knowledge gained. We specialize in facilitating container deployments and implementing serverless architectures within AWS. We value versatility and enthusiasm in our DevOps Software Engineers, encouraging them to tackle new challenges with vigor. We strongly believe that fostering diversity of perspectives, ideas, and cultures is integral to our success in creating superior products. By embracing varied backgrounds and insights, we enhance innovation and achieve excellence in our endeavors. Required Qualifications: Object Oriented Programming experience. Experience with AWS (e.g., CloudFormation, EC2, Lambda, DynamoDB, and ElasticSearch) Experience with relational databases (e.g., RDS, Oracle, Postgres) Experience in continuous integration technology (e.g., Chef, Puppet, Docker, Jenkins, Ansible) Experience with interacting in a Linux environment (ex - Bash scripting BS/BA in Computer Science OR equivalent combination of education and experience Desired Qualifications: Experience with Java, JavaScript, Python, Ruby Experience with application platforms such as Spring Boot or Angular Experience with log analytics tools such as Splunk or ElasticSearch. Experience working with containers using Docker. Experience with container orchestration systems such as Kubernetes and Mesos Experience in communicating with users, technical teams, and senior management. Comfortable working in a fast-paced environment Comfortable managing competing priorities and are able to bring order to ambiguous scenarios. Familiarity with Source code management and integration (ex - GitHub/GitLab) Experience in an Agile environment (JIRA, Confluence) Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. VA Red Rock is an Equal Opportunity Employer. We are always searching for strong technical talent to help us serve our DoD and IC customers around the Washington, DC metro area. We are constantly in need of developers, designers, architects, engineers, QA/testers, cyber security specialists and more . CJ123

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. BD is searching for a Staff Systems Engineer to join our rapidly expanding Pharmacy Automation Systems Engineering team. System Engineers are characterized by their disciplined, quantitative approach to system and technology integration as well as diverse cross-functional backgrounds and general knowledge of related disciplines. These individuals deploy tools and processes such as Design for Six Sigma and product development processes (waterfall, Agile) within a quality management system to enable more predictable product development and high quality products. System Engineers are responsible for technology integration in systems that have both enterprise software and electromechanical (hardware / embedded software) components. The Systems Engineer is a key member of the team and will contribute to system-level definition, design, and testing for robotic systems through close collaboration with hardware design, software, and other functional groups. Main responsibilities will include: Ownership of Systems Engineering inputs and outputs for teams supporting innovation, new product development, or product lifecycle management. Responsibility for development and maintenance of system/product design architecture and system/product requirements. Document system/product-level requirements and manage changes via team review, approval, and release processes. Lead the definition and documentation of system interfaces and interface requirements. Ensure design traceability from user needs through requirements to test evidence and support the use of appropriate software tools for the creation and maintenance of the trace matrices. Lead system/product-level integration, bug/defect tracking and configuration management. Lead the system evaluation process through development and execution of system level test plans and protocols including data analysis, interpretation and communication of results and their impact through written reports, design reviews, and interactive discussions. Lead system verification and validation activities for a multi-functional project team including protocol writing, execution and reporting. Contribute to the transition from R&D to manufacturing/service and support resolving system issues for products in the field. Liaise between R&D and other functions to inform/support teams based on quality procedures including risk analysis and verification/validation for specific subsystems. Education and Experience Must have a bachelor's degree in science or engineering (5+ years of experience in technical area). A postgraduate degree is preferred. Background in electro/mechanical devices and/or automation A strong technical background and experience within Systems Engineering - Requirements Management, Hazards Analysis, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Reliability Engineering, and Failure Modes Effects Analysis. Proven track record developing complex experiments independently, performing statistical analysis, interpreting experimental results, and making informed recommendations. Apply creative problem-solving skills to novel or complex applications. Ability to self-direct and manage own work Ability to collaborate in multi-disciplinary team settings, influence decision making, and build group consensus. Strong problem-solving and debugging skills and an interest in learning new technologies. Excellent written and oral communication skills Experience implementing and educating others in Design for Six Sigma (DFSS) methodologies is a bonus. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA NC - Durham - Roche DriveAdditional LocationsWork Shift

Red Rock Government Services is a leading software engineering company recognized for its exceptional support to the intelligence community. With a proven track record of delivering innovative and mission-critical solutions, Red Rock specializes in developing secure, scalable, and cutting-edge technologies tailored to meet the complex needs of intelligence operations. The company's expertise in advanced analytics, cloud computing, and artificial intelligence enables it to empower agencies with enhanced decision-making capabilities and operational efficiency. Red Rock's commitment to excellence, agility, and collaboration solidifies its reputation as a trusted partner in safeguarding national security and advancing intelligence objectives. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. At Red Rock, our DevOps Software Engineers champion state-of-the-art IT solutions by collaborating closely with cross-functional teams and actively sharing knowledge gained. We specialize in facilitating container deployments and implementing serverless architectures within AWS. We value versatility and enthusiasm in our DevOps Software Engineers, encouraging them to tackle new challenges with vigor. We strongly believe that fostering diversity of perspectives, ideas, and cultures is integral to our success in creating superior products. By embracing varied backgrounds and insights, we enhance innovation and achieve excellence in our endeavors. Required Qualifications: 5+ years of DevOps experience 3+ years of experience with Continuous Integration/Continuous Development (CI/CD) 3+ years of Kubernetes experience, including writing Kubernetes scripts 3+ years of Docker experience Hands-on experience supporting cloud-agnostic environments Experience integrating automated test tools into CI/CD pipelines Strong background with Linux operating systems Proven ability to develop, implement, and maintain complex functions and scripts for cloud services Experience working in an Agile environment Proficiency with Git Optional Skills Experience building security-hardened images Familiarity with infrastructure automation tools (e.g., Terraform) Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. VA Red Rock is an Equal Opportunity Employer. We are always searching for strong technical talent to help us serve our DoD and IC customers around the Washington, DC metro area. We are constantly in need of developers, designers, architects, engineers, QA/testers, cyber security specialists and more . CJ123

Job Description Red Rock Government Services is a leading software engineering company recognized for its exceptional support to the intelligence community. With a proven track record of delivering innovative and mission-critical solutions, Red Rock specializes in developing secure, scalable, and cutting-edge technologies tailored to meet the complex needs of intelligence operations. The company's expertise in advanced analytics, cloud computing, and artificial intelligence enables it to empower agencies with enhanced decision-making capabilities and operational efficiency. Red Rock's commitment to excellence, agility, and collaboration solidifies its reputation as a trusted partner in safeguarding national security and advancing intelligence objectives. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. At Red Rock, our DevOps Software Engineers champion state-of-the-art IT solutions by collaborating closely with cross-functional teams and actively sharing knowledge gained. We specialize in facilitating container deployments and implementing serverless architectures within AWS. We value versatility and enthusiasm in our DevOps Software Engineers, encouraging them to tackle new challenges with vigor. We strongly believe that fostering diversity of perspectives, ideas, and cultures is integral to our success in creating superior products. By embracing varied backgrounds and insights, we enhance innovation and achieve excellence in our endeavors. Required Qualifications: 5+ years of DevOps experience 3+ years of experience with Continuous Integration/Continuous Development (CI/CD) 3+ years of Kubernetes experience, including writing Kubernetes scripts 3+ years of Docker experience Hands-on experience supporting cloud-agnostic environments Experience integrating automated test tools into CI/CD pipelines Strong background with Linux operating systems Proven ability to develop, implement, and maintain complex functions and scripts for cloud services Experience working in an Agile environment Proficiency with Git Optional Skills Experience building security-hardened images Familiarity with infrastructure automation tools (e.g., Terraform) Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. VA Red Rock is an Equal Opportunity Employer. We are always searching for strong technical talent to help us serve our DoD and IC customers around the Washington, DC metro area. We are constantly in need of developers, designers, architects, engineers, QA/testers, cyber security specialists and more . CJ123

Job Description Red Rock Government Services is a leading software engineering company recognized for its exceptional support to the intelligence community. With a proven track record of delivering innovative and mission-critical solutions, Red Rock specializes in developing secure, scalable, and cutting-edge technologies tailored to meet the complex needs of intelligence operations. The company's expertise in advanced analytics, cloud computing, and artificial intelligence enables it to empower agencies with enhanced decision-making capabilities and operational efficiency. Red Rock's commitment to excellence, agility, and collaboration solidifies its reputation as a trusted partner in safeguarding national security and advancing intelligence objectives. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. RedRock is currently seeking a DevOps Software Engineer to join our team of diverse and qualified professionals. In this role, you will play a key part in advancing our mission of delivering cutting-edge language training to ensure proficiency across a wide range of languages for the Sponsor's employees. DevOps Software Engineers contribute to the development of state-of-the-art IT solutions, working closely with cross-functional teams and sharing valuable insights and lessons learned. The role emphasizes facilitating container deployments and implementing serverless architectures within AWS. We value versatility and enthusiasm in tackling new challenges. At RedRock, we believe that hiring exceptional talent and fostering diversity of perspectives, ideas, and cultures are essential to creating superior products. Requirements: BS/BA in Computer Science OR equivalent combination of education and experience Object Oriented Programming experience. Experience with AWS (e.g., CloudFormation, EC2, Lambda, DynamoDB, and ElasticSearch) Experience with relational databases (e.g., RDS, Oracle, Postgres) Experience in continuous integration technology (e.g., Chef, Puppet, Docker, Jenkins, Ansible) Experience with interacting in a Linux environment (ex - Bash scripting) Desired Qualifications: Experience with Java, JavaScript, Python, Ruby Experience with application platforms such as Spring Boot or Angular Experience with log analytics tools such as Splunk or ElasticSearch Experience working with containers using Docker. Experience with container orchestration systems such as Kubernetes and Mesos Experience in communicating with users, technical teams, and senior management. Comfortable working in a fast-paced environment Comfortable managing competing priorities and are able to bring order to ambiguous scenarios. Familiarity with Source code management and integration (ex - GitHub/GitLab) Experience in an Agile environment (JIRA, Confluence) Location: Chantilly, VA Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. VA Red Rock is an Equal Opportunity Employer. We are always searching for strong technical talent to help us serve our DoD and IC customers around the Washington, DC metro area. We are constantly in need of developers, designers, architects, engineers, QA/testers, cyber security specialists and more . CJ123

Job Description Red Rock Government Services - Discover a company you'll love to work for... Red Rock Government Services is a Woman-owned Small Business consultancy providing strategic, IT, financial, and management consulting services to the federal government within the national security environment. We are mission-focused in creating value for our customers and people-focused in providing fulfilling career and growth opportunities for our employees. We offer a generous compensation package with employee incentives, above industry-standard benefits, and a strong focus on work-life balance. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. RedRock is actively seeking a proficient Software Developer specializing in independent work within a dynamic Agile scrum software development environment. The ideal candidate will possess extensive experience in utilizing agile development tools and methodologies to foster collaboration within Agile team frameworks. Required Skills: Proficiency in developing and maintaining applications using: Angular Node.js JavaScript Bootstrap or Material Design Browser technologies (HTML, HTTP, CSS) Elasticsearch ELK stack AWS (desired) MongoDB (desired) Cypress (desired) Experience with key tools and platforms: JIRA for maintaining stories and tasks. Confluence for collaboration Unit testing methodologies GitHub for version control Jenkins (desired) for automation Familiarity with: DevOps practices, build automation, and continuous integration (desired) Strong skills in: Participating in daily stand-ups Engaging in technical discussions, forums, and retrospectives Contributing to routine customer meetings and ad hoc sessions Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law.

#LI-Onsite This position will be located at Durham, NC and will not have the ability to be located remotely. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. A Bioprocess Engineer Downstream/Fill-Finish plays a critical role in the manufacturing operations at a plant or site. This position is pivotal in ensuring the smooth execution of production processes, organizing and running operations effectively, and continuously improving the manufacturing workflow. Role Responsibilities: Performs commercial and clinical manufacturing operations on-site, including purification (downstream), fill-finish (drug product, visual inspection, packaging), media/buffer preparation, and any additional supporting activities. Troubleshoot equipment, collaborate with other business units to aid in manufacturing-led deviations, standardize equipment, and clean production areas. Assists in identifying root causes, implementing solutions, and verifying the effectiveness of those solutions. Contributes to the creation and ongoing maintenance of all pertinent equipment policies and procedures. Acquires and applies aseptic techniques relevant to cell culture, recovery, purification, aseptic fill/finish (upstream and downstream). Supports product requirements to ensure that all products are manufactured according to plan. Learns cGMP and cGDP protocols, ensures accurate completion of cGMP documentation, maintains current training, and adheres to all quality standards. Maintains quality standards to meet cGMP requirements, CFRs, and internal company policies directly related to the manufacturing process. Collaborates with the Quality department to ensure a compliant manufacturing environment Shift: This role is a 2-2-3 day shift position. 5:45am-6:15pm Role Requirements: **The level of the role will be determined by the years of relevant experience. For Bioprocess Engineer I - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field or 2 years equivalent experience; For Bioprocess Engineer II - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 2 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; OR four (4) years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree; For Bioprocess Engineer III - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 4 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; OR six (6) years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree Excellent oral and written communication skills Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between: for Bioprocess Engineer I, $22.84 and $42.46; for Bioprocess Engineer II/III, $32.12 and $59.62, per hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Company will not sponsor visas for this position. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $66,800.00 - $124,000.00 Skills Desired Assembly Language, Cooperation, Efficiency, Electronic Components, Flexibility, General Hse Knowledge , Good Documentation Practice, Installations (Computer Programs), Iso (International Organization For Standardization), Job Description, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Nuclear Medicine, Physics, Product Distribution, Production Line, Scheduler

About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience. Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK , for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values. Job Description Summary: Krystal Biotech, Inc is seeking a highly motivated and dynamic Bioprocess Engineer to support our product manufacturing at our Pittsburgh GMP facility. This role is critical to our make a meaningful difference in the lives of underserved patient populations having rare diseases. Quality, safety and on-time delivery is a must to be successful in this role! The ideal candidate will have foundational experience in upstream and/or downstream biologics or gene therapy manufacturing. Primary Responsibilities: Perform/support/monitor the process steps/activities - buffer preparation, upstream, downstream, Aseptic Fill Document/record data following standard operating procedures or GMP documents for process steps and/or equipment activities Maintain equipment and operate - facilitate/perform qualifications, cleaning, logbooks Clean, maintain, and monitor the GMP facility Collaborate with Quality assurance, Quality control, Facilities, Materials and others Participate in learning and training to be competent in above functions Other duties as assigned Requirements and Preferred Qualifications: Bachelor's degree, preferably in life sciences Expertise working in a clean room facility, 1+ years of professional experience demonstrating proper cleanroom behavior/technique Cell culturing / Aseptic technique Familiarity with large scale bioreactors highly preferred Downstream processing experience Filtration/Purification Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking Highly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure A demonstrated understanding of the drug development process, biopharmaceutical industry and/or related life sciences industry Demonstrated ability to prioritize and manage multiple projects simultaneously Demonstrated ability to work effectively with many different types of personalities at all levels of the organization Excellent interpersonal, collaboration and stakeholder management skills Excellent communication skills (written/verbal) Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc. Powered by JazzHR fUkTRwFDa4

About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience. Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values. Job Description Summary: Krystal Biotech, Inc is seeking a highly motivated and dynamic Bioprocess Engineer to support our product manufacturing at our Pittsburgh GMP facility. This role is critical to our make a meaningful difference in the lives of underserved patient populations having rare diseases. Quality, safety and on-time delivery is a must to be successful in this role! The ideal candidate will have foundational experience in upstream and/or downstream biologics or gene therapy manufacturing. Primary Responsibilities: * Perform/support/monitor the process steps/activities - buffer preparation, upstream, downstream, Aseptic Fill * Document/record data following standard operating procedures or GMP documents for process steps and/or equipment activities * Maintain equipment and operate - facilitate/perform qualifications, cleaning, logbooks * Clean, maintain, and monitor the GMP facility * Collaborate with Quality assurance, Quality control, Facilities, Materials and others * Participate in learning and training to be competent in above functions * Other duties as assigned Requirements and Preferred Qualifications: * Bachelor's degree, preferably in life sciences * Expertise working in a clean room facility, 1+ years of professional experience demonstrating proper cleanroom behavior/technique * Cell culturing / Aseptic technique * Familiarity with large scale bioreactors highly preferred * Downstream processing experience * Filtration/Purification * Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking * Highly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure * A demonstrated understanding of the drug development process, biopharmaceutical industry and/or related life sciences industry * Demonstrated ability to prioritize and manage multiple projects simultaneously * Demonstrated ability to work effectively with many different types of personalities at all levels of the organization * Excellent interpersonal, collaboration and stakeholder management skills * Excellent communication skills (written/verbal) Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.