Equipment validation engineer jobs near me

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Equipment Validation Engineer - North America
Becton Dickinson Medical Devices 4.3
Equipment validation engineer job in Columbus, OH
SummaryThe role of Global Integrated Engineering is to support all BD manufacturing sites globally in their capital deployment of “break-through” and capacity / replacement programs to meet business growth needs. The role is to drive the integration and manage the end-to-end implementation of process and equipment at BD appointed production sites working in partnership with the sites for a seamless transition and rapid startup. Develops Strategies, Collaborates and Communicates with: Program Managers: To ensure that the integrated equipment / processes are delivered on time/within budget and to required quality standards. Quality Team: To ensure that the integrated equipment / processes meet necessary quality / regulatory standards. Manufacturing & Operations Team: To ensure that the integrated equipment / processes are easy to operate, maintain, reliable and that equipment is operating efficiently / effectively from handover / hyper care to meet production targets. Suppliers and Vendors: To source and integrate equipment technologies while ensuring project milestones are met. Equipment Design Team: To ensure that equipment is designed, built, and tested to meet production requirements. Finance team: For CapEx spending reporting.Job 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. RESPONSIBILITIES Participate at FAT and SAT with EDE team. Prepare an installation plan and full validation of equipment. Manage the integration of new equipment validation, and vertical start-up into the existing manufacturing process ensuring the training plan and competence assessments are completed. Ensure minimal disruption to ongoing operations during equipment or software integration, addressing any issues or roadblocks. Support the documentation of equipment instruction and process parameters and support the site for training on the new equipment and application. During the ramp up phase, provide ongoing technical assistance during the ramp up phase to support maintaining long term capability, OEE target and CI initiatives. Consolidate opportunities identification to improve integration processes, tools methodologies, staying current with industry best practices and emerging technologies. Ensure equipment and installation conforms to Environmental Health and Safety, international standards and company policies to include lock-out tag-out, controls, guarding, etc. Measure and oversee performance on the operability of the equipment, ensuring optimal performance, minimizing downtime. Oversee existing tools and resources needed to support equipment maintenance programs, center lining procedures, and to ensure reliability and up-time. Coordinate the handover to other departments (i.e. operations/maintenance/quality) to ensure smooth production ramp-up / alignment with overall company objectives. Manage adherence to production ramp-up plans to ensure that newly installed equipment meets performance targets. Ensure all gaps between expected and actual performance of new CapEx integration during the ramp up phase. Resolve integration plans and schedules which covered of resources, timeline, and key milestones. Execute test plans to verify functionality, process windows, performance, and reliability of equipment (i.e. FAT, SAT, Validation, Commissioning, etc.) Perform center lining of equipment to optimize the equipment performance. Execute the diagnoses and resolution of integration issues, working closely with respective engineering teams or vendors to identify root causes and implement corrective actions. Perform equipment documentation, including document creation, data compilation & document hand-over, in terms of equipment architecture diagram, specifications, test reports, maintenance and control plans. Support collaboration with various engineering teams or vendors (i.e. mechanical / electrical / software) to ensure smooth integration of respective equipment, subsystems, and components. Specific Process Equipment Lead team in problem solving - identification of Equipment & Automated Systems problems and analysis of the root cause. Troubleshoot Equipment systems processes and material or equipment issues through scientific approaches and tools. Support Proof of Concept (POC) evaluation and Design Of Experiments (DOE), establish baseline process and metrics for Equipment & Automated Systems. Verify a relationship between Equipment & Automated Systems Key Process Input Variables ( (KPIVs) and Key Process Output Variables (KPOVs). Responsible for execution of process verification, process validation and production ramp-up activities for Equipment & Automated Systems. Leading KPI Accountable for Integration lead time reduction (Time): 10% on Focus lines / 30% on New lines Accountable for Improved equipment performance (OEE) through validation: +10% vs Focus M/c's / >82% @ on New Line Lagging KPI Accountable for# of accidents attributable to the introduction of new capital equipment by GIE Drive GIE VoA Index Improvement vs. ISC Baseline (72 Org Commitment) measured at the next survey point (GIE Pulse) Minimum Requirements: Bachelor's degree in Engineering (Electrical, Mechanical, Controls, Automation) or Project Management, preferred. 5 years of progressively responsible engineering and project management experience. Extensive experience in integrating equipment within complex manufacturing sites with a strong focus on validation and vertical start up. Proven lean leadership experience who can assimilate data in a structured manner and present recommendations based on facts and data. Proven leadership in project and capital management. Exceptional communication and presentation skills. Ability to travel up to 50% of the time In BD we have embraced the use of digital technology to collaborate effectively with our teams around the world. Additionally, we also value team member growth through providing opportunities to make an impact beyond the home location when needs arise. In such instances, our objective is to distribute these opportunities between all team members, seeking their acceptance to travel whilst lending their expertise to meet the needs of the business through the projects they support. And, while it's difficult to predict and quantify the amount for any individual in advance, regionally aligned associates could incur periodic travel up to half of their working time subject to any entry requirements governed by the countries being visited. Note: In all cases, we will strive to minimize travel as much as possible and any amount of travel is not intended to be an ongoing weekly requirement 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. BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families. Competitive pay Access a portion of your pay before pay day with DailyPay Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover. Preventive care covered at 100%. Dental and vision insurance at group rates. Paid parental leave up to 6 weeks Adoption assistance plan 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation Company paid basic life and AD&D insurance Tuition reimbursement Discounted home, auto and pet insurance Paid holidays and vacation (pro-rated the first year based on actual start date) All benefits and policies are subject to eligibility and enrollment requirements. Most coverage begins on your first day or the date you become eligible for benefits. 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 NE - Columbus (West) Additional LocationsWork ShiftNA (United States of America)
$71k-88k yearly est. Auto-Apply 42d ago
Lead Validation Specialist
Theradex Oncology 4.1
Remote equipment validation engineer job
Who We Are Celebrating 40+ years! Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials. What You'll Do As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference. Opportunity Lead Validation Specialist Location: Princeton NJ and Remote - Preference given to applicants residing in the East Coast. We are seeking an experienced Senior Validation Specialist with experience in clinical systems to join our team. In this role, you will provide project leadership for the validation team and be responsible for ensuring that clinical systems are validated and maintained in compliance with GxP regulations and 21 CFR Part 11. You'll work cross-functionally with validation, developers and SMEs to support rapid development timelines while upholding regulatory standards. You'll be responsible for creating, executing, and maintaining validation strategies and documentation where scope and requirements can shift quickly. This is an ideal opportunity for someone who thrives in fast-paced, dynamic environments where adaptability, critical thinking, and initiative are essential. What You Need Bachelor's degree 8+ years prior experience inclusive of computer systems validation 5+ Years relevant experience in Leading a Validation Team Strong experience working with relational databases (Oracle, MS SQL) to ensure data integrity in compliance with ALCOA+ Knowledge and understanding of Regulatory Guidelines for the use of computer systems Experience working with GxP regulations and 21 CFR Part 11 Experience mentoring and coaching teams Prior experience working in a Life Science regulated industry Prior project management experience, preferred Skills and Competencies Computer Systems and Technology: Strong knowledge of computer systems validation (SDLC, Agile methodologies) web technology, and cloud-based systems and proficiency with Computer skills including advanced knowledge of excel (e.g. Microsoft Word, Excel spreadsheets, PowerPoint, SQL) Analytical and Problem-Solving Skills: Ability to research, analyze system requirements, develop alternatives, and implement solutions Communication and Interpersonal Skills: Strong verbal and written communication skills as well the ability to work both independently and with cross-functional teams Time Management Skills: Highly organized, result-oriented, and a self-starter comfortable working in fast-paced environment with evolving priorities Additional Requirements Able to work effectively as an onsite or remote worker Must be highly fluent in English Willing to travel to meetings in Princeton, NJ as needed. Advance notice will be provided What We Offer At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $125,000-150,000 with bonus potential. The actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role. This position is not eligible for relocation or company provided sponsorship. Theradex is an Equal Opportunity Employer.
$125k-150k yearly Auto-Apply 13d ago
Compliance Validation Specialist - Part Time & Remote
Testpros
Remote equipment validation engineer job
TestPros is a successful and growing business, established in 1988 to provide Information Technology (IT) technical support services to a wide range of Commercial and U.S. Federal, State, and Local Government customers. Our capabilities include Program Management, Program Oversight, Process Audit, Intelligence Analysis, Cyber Security, NIST SP 800-171 Assessment and Compliance, Computer Forensics, Software Assurance, Software Testing, Test Automation, Section 508 and WCAG Accessibility Assessment, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance, and Research and Development (R&D) services. TestPros is an Equal Opportunity Employer. TestPros delivers innovative independent IT assessment solutions to critical challenges facing the nation and the world. We support the U.S. Federal Government and Commercial clients within the continental USA. TestPros is dedicated to making lives better, safer and more secure. Job Summary TestPros is seeking a qualified consultant to ensure its websites and mobile applications comply with Web Content Accessibility Guidelines (WCAG) 2.1 Level AA standards as mandated by the U.S. Department of Justice's (DOJ) 2024 final rule under Title II of the Americans with Disabilities Act (ADA). This project aims to improve digital accessibility for individuals with disabilities and align the digital platforms with federal accessibility requirements. Position: Part time (as needed, 1099 or Corp. to Corp) Citizenship: U.S. Citizenship or Green card holder Location: Remote Clearance: None Responsibilities: Re-assess websites and mobile applications post-remediation to confirm WCAG 2.1 compliance. Conduct certification or validation processes for accessibility standards. Deliver final compliance reports, documenting validation results. Qualifications: Expertise in evaluating web and mobile platforms against WCAG 2.1 AA requirements. Familiarity with compliance certification processes. Strong attention to detail and thorough understanding of accessibility testing methods. Proven ability to work with regulatory standards and certifications. Benefits TestPros offers a competitive salary, medical/dental/vision insurance, life insurance, paid time off, paid holidays, 401(k) retirement plan with company match, opportunities for professional growth, cell phone discounts, and much more! All benefits are per TestPros current policies and are subject to change without notice. Benefits are available to full-time employees. TestPros, Inc. is an Equal Opportunity Employer. EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, marital status, age, national origin, protected veteran status, or disability. VEVRAA Federal Contractor.
$77k-104k yearly est. Auto-Apply 60d+ ago
DRG Validation Specialist
Maine Health 4.4
Remote equipment validation engineer job
MaineHealth Corporate Professional - Clinical MaineHealth is actively recruiting for a DRG Validation Specialist. This is a 100% remote opportunity. The DRG Validation Specialist job functions will include: * reviews codes to validate DRG assignment * appeals external audits * processes Cloudmed recommendations * resolves DRG matches between CDI and coding * answers coding questions * identifies opportunities for query composition improvement/compliance * identifies educational needs * creates educational materials Required Minimum Knowledge, Skills, and Abilities (KSAs) * Education: Associate's and/or Bachelor's Degree in Health Information Management or other science based degree such as Nursing required. * License/Certifications: Registered Health Information Technician (RHIT), Registered Health Information Administrator (RHIA), or Certified Coding Specialist (CCS) required. * Experience: Three years of experience as an inpatient coder at a large acute care or academic teaching facility required. * Additional Skills/Requirements Required: N/A * Additional Skills/Requirements Preferred: Advanced coding skills and knowledge of revenue cycle, billing systems, EPIC Electronic Health Record and 3M Encoder, ICD 10 training, Computer Assisted Coding software (CAC) In addition to the KSA's above, the successful candidate should also have the following skill sets: * Auditing experience * Strong oral and written communication skills * Critical thinking and strong organizational skills Additional Information With a career at any of the MaineHealth locations across Maine and New Hampshire, you'll be working with health care professionals that truly value the people around them - both within the walls of the organization and the communities that surround it. We offer benefits that support an individual's needs for today and flexibility to plan for tomorrow - programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family.
$86k-105k yearly est. 30d ago
Sr. Validation Engineer
VWR, Part of Avantor 4.8
Remote equipment validation engineer job
The Opportunity: Avantor is looking for a Sr. Validation Engineer to provide specialized knowledge in developing the strategy for equipment for processes and works with the validation team to ensure proper installation, operational and performance qualification of each piece of equipment up to and including all associated documentation. This includes products for medical device, excipient and bio-pharma manufacturing. Prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. The Sr. Validation Engineer is responsible for the theory and content of validation documents for equipment, processes, systems, software, changes and on-going review and revalidation of said items to ensure that validation documentation is compliant with validation requirements and policies. Provides facility, equipment and process qualification technical expertise. Author validation documents and execute validations of equipment, control systems and production processes. Directs the life cycle of launched products to support development of manufacturing processes, drive right-first time metrics, and reduce product rejects. Has responsibility for self-identification of process optimization opportunities, and detailed assessment of opportunities (process risk, financial cost/benefits, etc.). Participates in cross-functional assessments, as required to evaluate optimization opportunities/issues. Coordinate and lead validations to assure compliance with customer's requirements, ISO 9001 & 13485, 21 CFR 210 & 211, 21CFR 820 ICH Q7 and IPEC for all departments within Avantor. This role will be a hybrid position based out of our Solon, Ohio facility (or near other Avantor sites - St. Louis, Kentucky, Phillipsburg, NJ) with 25% travel for projects. What we're looking for: Education: BS degree in Engineering or Life Science (Chemistry, Bio, Physics, etc.) preferred Experience: 5+ years of experience in an Equipment, Cleaning, and/or Process Validation Engineering experience within a pharmaceutical or medical device company Knowledge of Industrial Quality Control, Quality Engineering, Quality Assurance and Validation, CFRs and their application to Medical Devices Knowledge of software packages supporting statistical data analysis, word processing, flow charting, and project management Familiarity and understanding of manufacturing methods related to the production of medical devices and related products Familiarity and understanding of technical disciplines related to Quality Control, including Engineering and process controls Strong communication skills, both verbal and written; ability to work and interface with all levels Use of computers and peripherals related to validation execution and document authoring Ability to work independently and as a team member, as well as, with Consultants/Contractors to achieve projects' validation objectives Ability to analyze, investigate and propose approaches to technical and regulatory issues Ability to manage multiple concurrent tasks/studies Ability to execute the Validation Plans for medical device and related product manufacturing equipment and facilities Ability to travel to other sites. How you will thrive and create an impact: Interface effectively with management personnel in IT, Engineering, Quality, R&D, Sales and other technical disciplines. Provide technical decision making regarding validation strategies and requirements for large scale and complex projects. Author and approve validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes. Perform, coordinate, and manage qualification testing. Represent Company in contacts with regulatory agencies, including interface with FDA inspectors and presentations to FDA management personnel in regards to validation activities. Coordinate the DQ, IQ, OQ, PQ and PV of all validation activities to assure compliance with customer requirements, ISO 9001 & 13485, 21 CFR 210 & 211, 21CFR 820 ICH Q7 and IPEC. Identify any areas for improvement and propose / implement approved necessary changes. Prepares, writes, and reviews validation protocols, Master Validation Plan (MVP), and documentation to ensure compliance and adherence to AVANTOR's SOP's, Customer specifications, ISO9001, ISO 13485, 21CFR820 and other applicable regulations. This includes regulatory bodies in the US and International. Maintains all Validations and assures they are updated as required. Periodic review is established based on a data review of quality inputs and outputs to assure outcome is as expected. Review need for validation with design group all processes, equipment, methods etc. Responsible for performing validation and managing large size validation projects and supervising technicians/engineers, providing necessary leadership and guidance. Responsible for the generation of protocols using a risk based approach that meets current regulatory requirements and industry practices, as well as performing design qualification. Responsible for managing to validation metrics. Performs other duties as assigned Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer. Why Avantor? Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science. The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor. We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today! Pay Transparency: The expected pre-tax pay for this position is $77,300.00 - $128,700.00 Actual pay may differ depending on relevant factors such as prior experience and geographic location. EEO Statement: We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at ****************************** and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. For more information about equal employment opportunity protections, please view the Know Your Rights poster. 3rd Party Non-Solicitation Policy: By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation. Avantor offers a comprehensive benefits package including medical, dental, and vision coverage, wellness programs, health savings and flexible spending accounts, a 401(k) plan with company match, and an employee stock purchase program. Employees also receive 11 paid holidays, accrue 18 PTO days annually, are eligible for volunteer time off and 6 weeks of 100% paid parental leave (except in states that offer paid family leave). These benefits may not apply to employees covered by a collective bargaining agreement or those subject to other eligibility rules.
$77.3k-128.7k yearly Auto-Apply 4d ago
Senior Battery Validation Engineer
Ford Global
Remote equipment validation engineer job
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, we're all a part of something bigger than ourselves. Are you ready to change the way the world moves? Ford's Electric Vehicles, Digital and Design (EVDD) team is charged with delivering the company's vision of a fully electric transportation future. EVDD is customer-obsessed, entrepreneurial, and data-driven and is dedicated to delivering industry-leading customer experience for electric vehicle buyers and owners. You'll join an agile team of doers pioneering our EV future by working collaboratively, staying focused on only what matters, and delivering excellence day in and day out. Join us to make positive change by helping build a better world where every person is free to move and pursue their dreams. In this position... The Battery Validation Engineer will be responsible for enabling innovation through quick testing and characterization of battery components and systems. This individual will define test plans, execute them safely, and report results in order to successfully validate Ford's next generation of EV batteries. You'll have… Bachelor's degree in engineering or related field 5+ years of experience in battery testing and validation Experience with battery test equipment, instrumentation, and data acquisition systems Knowledge of battery chemistry, physics, and safety standards Ability to work independently and collaboratively in a fast-paced environment Strong problem-solving, communication, and project management skills Knowledge of statistical analysis and design-of-experiment Experience in test fixture design and fabrication; 3-D CAD experience preferred Experience in structural, electrical, thermal, and mechanical systems Familiarity with US and international battery safety requirements/regulations Hands-on experience in HV battery system abuse testing Ability to travel to external test labs as needed Even better, you may have… Master's degree in engineering Hands-on experience building and launching automotive products Experience in configuration, development and maintenance of automated test systems Strong written and verbal communication skills Experience using Confluence, Jira, Jama, or other project management tools An eagerness to work cross-functionally in a dynamic environment where you are part of a high performing team A system approach to design and development with the desire and curiosity to strive for exceptional delivery execution and continuous improvement You may not check every box, or your experience may look a little different from what we've outlined, but if you think you can bring value to Ford Motor Company, we encourage you to apply! As an established global company, we offer the benefit of choice. You can choose what your Ford future will look like: will your story span the globe, or keep you close to home? Will your career be a deep dive into what you love, or a series of new teams and new skills? Will you be a leader, a changemaker, a technical expert, a culture builder…or all of the above? No matter what you choose, we offer a work life that works for you, including: • Immediate medical, dental, vision and prescription drug coverage • Flexible family care days, paid parental leave, new parent ramp-up programs, subsidized back-up child care and more • Family building benefits including adoption and surrogacy expense reimbursement, fertility treatments, and more • Vehicle discount program for employees and family members and management leases • Tuition assistance • Established and active employee resource groups • Paid time off for individual and team community service • A generous schedule of paid holidays, including the week between Christmas and New Year's Day • Paid time off and the option to purchase additional vacation time. This position is a salary grade 8. For more information on salary and benefits, click here: ***************************** This position is a range of salary grades 5-8 . Visa sponsorship is available for this position. Candidates for positions with Ford Motor Company must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, disability status or protected veteran status. In the United States, if you need a reasonable accommodation for the online application process due to a disability, please call **************. Onsite work of up to four days per week may be required for candidates within commuting distance of a Ford hub location. #LI-Hybrid #LI-HA1 What you'll do... Plan, coordinate, and execute battery pack validation tests covering various categories including performance, durability, and abuse Author test scripts for equipment including cyclers, chambers, chillers, and DAQ systems Own data storage and visualization Analyze test data and generate test reports, evaluating compliance with requirements and identifying issues or opportunities for improvement Work alongside systems engineers to define requirements Work alongside cell engineers to define test profiles and correlate cell and pack results Work alongside prototyping and logistics teams to coordinate sample assembly and delivery Work cross-functionally across engineering, manufacturing, quality, and service to communicate test results and provide feedback on battery design and integration Assist battery part owners to develop component-level tests Setup data acquisition systems and specialized measurement equipment as needed Work with fabrication team as needed to design and build custom fixtures Manage external vendors and partners for additional testing capabilities
$91k-122k yearly est. Auto-Apply 60d+ ago
Process Validation Engineer, Expert
Agilent Technologies, Inc. 4.8
Remote equipment validation engineer job
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at **************** The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines. Agilent Technologies Nucleic Acids Solutions Division is looking to for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado. Job Description As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: * Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. * Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents. * Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. * Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Support the design and execution of Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. * Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. * Provide work product updates to clients and project teams in the form of slides, memos and reports. * Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices. * Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing. Qualifications * Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field * Knowledge and 8+ experience in a GMP API setting. * Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process. * Knowledge and experience in process validation studies at the bench and in a plant setting. * Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable #LI-TH1 Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 17, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit ********************************* Travel Required: No Shift: Day Duration: No End Date Job Function: R&D
$105.3k-164.5k yearly Auto-Apply 25d ago
Senior Navy Qualified Validator
Watershed Security
Remote equipment validation engineer job
Watershed Security, is a Veteran Owned Small Business with over 20 years' Cybersecurity and Government Contracting experiencing. Watershed is looking for a Intel Security Specialist to support the Naval Surface Warfare Center (NSWC) Dahlgren Division Dam Neck Anex (NSWCDD-DNA) in Dam Neck, VA. The successful candidates will have validating Navy RMF Packages as a Navy Qualified Validator (NQV). REQUIRED QUALIFICATIONS Highschool Diploma or GED required. Years of Experience: Ten (10) years of full-time experience performing Risk Management Framework (RMF) Validation for Navy systems Current Navy Qualified Validator (NQV) certification; Must be able to maintain IAM-III designation with at least one of the following active certifications: CISM, CISSP (or Associate), GSLC. Any level of demonstrated experience in all of the following areas: Performing STIG assessments to include using SCAP benchmarks and Evaluate STIG Performing vulnerability assessments with the Assured Compliance Assessment Solution tool Utilization and process execution within eMASS Developing Security Assessment Plans Performing Risk Assessments Completing full Risk Management Framework Package acting as the Validator Communicating risk reduction recommendations to stakeholders Clearance Level: SECRET; US Citizen. Ability to possibly provide onsite support in Dam Neck VA. Some/all remote work may be an option, however the norm will be onsite support. This will be dependent upon customer needs and classification level of work being performed. Some travel may be required. Proficient with Microsoft Office Suite (Word, Excel, Teams, Project). Self-Starter; detail oriented; able to brief senior level staff. DESIRED QUALIFICATIONS Experience supporting 10 or more Navy Packages (achieving and/or maintaining ATO) Experience with Navy Cybersecurity requirements; experienced with Navy compliance tools such as eMASSter Experience with the NAVSEA RMF Business Rules Contingent upon award PAY RANGE Final salary is influenced by factors such as location, contract labor categories, experience, skills, education, and certifications. Watershed offers competitive compensation, medical and dental benefits, educational reimbursement, 401K plans with matching, 15 days of PTO to start and 11 paid holidays per year. The proposed salary range for this position is: $100,000.00 - $115.000.00 USD. Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
$82k-110k yearly est. Auto-Apply 60d+ ago
Engineer II, Validation
Moderna Theraputics
Remote equipment validation engineer job
The Role In this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. This role will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and equipment remain in an operational state of compliance. Here's What You'll Do * Perform commissioning, qualification, and validation activities for Moderna's GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities. * Working with external validation service providers. Responsibilities and ensure commitment to key stakeholders are met. * Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards. * Support new equipment qualification activities for capital and operational projects. * Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments. * Provide support for equipment and systems in use at Moderna facilities (Controlled Temperature Units [Refrigerators, Freezer, Incubators], Analytical Instruments [used for in-process and quality control testing], Manufacturing Unit Operations [Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters], etc.). * Support internal and external audits/inspections as a part of Commissioning, Qualification and Validation program. * Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs. * Drive results by owning and completing validation initiatives / projects against identified timelines. * Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities. * Additional duties as may be assigned from time to time Here's What You'll Need (Basic Qualifications) * B.S. in Life Science or Engineering Degree (Mechanical, Computer Science or Biomedical Engineering Etc.). Master's degree in above discipline preferred. * Minimum of 2+ years in commissioning / qualification / validation /quality experience in cGMP manufacturing environments * Here's What You'll Bring to the Table (Preferred Qualifications) * Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE). * Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection. * Must be able use his / her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems. * Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required. * Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his / her manager. * Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner. * A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. * At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. * Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs * A holistic approach to well-being, with access to fitness, mindfulness, and mental health support * Family planning benefits, including fertility, adoption, and surrogacy support * Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown * Savings and investment opportunities to help you plan for the future * Location-specific perks and extras The salary range for this role is $72,500.00 - $116,000.00. 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 individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NB1 *
$72.5k-116k yearly Auto-Apply 34d ago
Validation Engineer
Syner-G
Remote equipment validation engineer job
Job Description : A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit *********************** POSITION OVERVIEW: We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program. We are actively seeking qualified candidates to join our talent pipeline for future client engagements. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification. Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR). Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures. Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities. Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments. Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes. Support the resolution of regulatory observations or manufacturing site issues. Execute periodic reviews and requalification for temperature chambers. QUALIFICATIONS AND REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Education : Bachelor's degree in a related life science field. Technical Experience : 4-7 years of experience within the biotech, pharmaceutical, or medical device industry. Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. Validation expertise in Equipment, CSV, Method, and Process. Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation. Report writing experience for IQ, OQ, PQ, and CSV. Knowledge, Skills, and Abilities : Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired. ESSENTIAL FUNCTIONS: Physical Demands : The physical demands described here are representative of the requirements 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. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $88,000 to $104,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.
$88k-104k yearly 5d ago
LL01-082525 Validation Specialist (Packaging) - Ohio
Validation & Engineering Group
Equipment validation engineer job in New Albany, OH
Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Specialist for Packaging Lines Equipment Periodic Review Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in commissioning, qualification and validation of packaging lines (Carton labeler, autoinjector labeler, buffer accumulator, Cartoner, case packer, palletizer, Systech Sentri vision systems) Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS), IQ, OQ, PQ, Periodic reviews protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). Strong knowledge in Packaging equipment. Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.
$63k-83k yearly est. 11d ago
Solution Validation Engineer
Latticesemi
Remote equipment validation engineer job
Lattice Overview There is energy here…energy you can feel crackling at any of our international locations. It's an energy generated by enthusiasm for our work, for our teams, for our results, and for our customers. Lattice is a worldwide community of engineers, designers, and manufacturing operations specialists in partnership with world-class sales, marketing, and support teams, who are developing programmable logic solutions that are changing the industry. Our focus is on R&D, product innovation, and customer service, and to that focus, we bring total commitment and a keenly sharp competitive personality. Energy feeds on energy. If you flourish in a fast paced, results-oriented environment, if you want to achieve individual success within a “team first” organization, and if you believe you can contribute and succeed in a demanding yet collegial atmosphere, then Lattice may well be just what you're looking for. Responsibilities & Skills Responsibilities: Perform system validation to assure the quality of solution stacks. Perform software validation to assure the quality of embedded software including Driver and Firmware. Perform software development tools testing such as Propel SDK, Builder and solution tool. Create the automation test suite/cases and develop automated testing scripts. Work with cross function teams for system and software validation. Required Skills, Experience BS/MS/PhD in Electronics or Computer Engineering with minimum of 10 years' experience of Embedded System/SW automation test development. Familiar with automated testing flow and framework. Programming skill with Python and C is a must, experiences in C++ or Java will be a plus. Experience in one or more of the following areas will be a plus: RISC architecture and micro-architecture (RISCV, ARM) Embedded Peripheral communication Protocols (PCIE, SPI, I2C, I3C, UART etc.) FPGA design flow Proficiency with bench equipment such as Oscilloscopes, Protocol Exerciser/Analyzers to perform system level validation on hardware. Strong written and verbal communication skills and the ability to work with multiple groups. Familiar with Windows/Linux OS. Strong teamwork spirit and be able to solve problems independently. Lattice recognizes that employees are its greatest asset and the driving force behind success in a highly competitive, global industry. Lattice continually strives to provide a comprehensive compensation and benefits program to attract, retain, motivate, reward and celebrate the highest caliber employees in the industry. Lattice is an international, service-driven developer of innovative low cost, low power programmable design solutions. Our global workforce, some 800 strong, shares a total commitment to customer success and an unbending will to win. For more information about how our FPGA, CPLD and programmable power management devices help our customers unlock their innovation, visit ******************** You can also follow us via Twitter, Facebook, or RSS. At Lattice, we value the diversity of individuals, ideas, perspectives, insights and values, and what they bring to the workplace. Applications are welcome from all qualified candidates. Lattice Feel the energy.
$71k-94k yearly est. Auto-Apply 1d ago
Validation Engineer
PSC Biotech 3.9
Equipment validation engineer job in Columbus, OH
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 experienced validation engineers responsible for the commissioning, qualification, and validation for pharmaceutical facilities, utilities, and equipment. 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 equipment and systems. Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures. Identify and assess risks associated with CQV activities and develop mitigation strategies. Troubleshoot and resolve issues related to equipment and process performance. Collaborate 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. Proven experience in equipment/facility/systems commissioning, qualification, and validation engineering 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. Travel is required. 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. 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 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-TP1
$69k-87k yearly est. 21d ago
Validation Engineer
Cai 4.8
Equipment validation engineer job in Columbus, OH
Are You Ready?CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard-through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. Our Foundational Principles- At CAI, we are committed to living our values-both professionally and personally:- We act with integrity- We serve each other- We serve society- We work for our future- We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity-always focused on how it will be done, not how it used to be done. Key Responsibilities1. Technical Responsibilities- Develop documentation for CQV activities- Write and execute protocols (field verification)- Develop summary reports at client sites2. Areas of Focus- Pharmaceutical facilities- Utilities- Equipment3. Project & Team Management- Plan and coordinate work- Direct small teams in document development and/or execution Qualifications and Experience- Bachelor's degree in a science or engineering field (or equivalent experience)- 2-4 years' experience in commissioning and qualification in a regulated industry- Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus- Preferred experience in:- Facilities and equipment startup- Walk-downs and troubleshooting- Utilities (WFI, RO, HVAC)- Upstream/downstream processing- Purification, recovery- Building automation- Pharmaceutical manufacturing processes Critical CompetenciesInfluence Strategy- Pursues initiatives aligned with organizational strategy- Identifies strategic, innovative solutions- Anticipates emerging customer/market needs Satisfy the Customer- Understands and anticipates customer needs- Delivers high-quality solutions and service- Proactively maintains satisfaction and loyalty Plan for Success- Aligns business strategies with actionable plans- Anticipates risks and builds contingency plans- Secures resources for goal achievement Pursue Execution- Prioritizes time and resources effectively- Holds self and others accountable- Acts to overcome obstacles and improve quality Tailor Communication- Communicates clearly and professionally- Adjusts style to fit the audience- Explains technical concepts effectively Build Partnerships- Builds networks across functions- Encourages collaboration and breaks down silos- Involves stakeholders in decisions Influence Others- Builds support with sound rationale- Gains buy-in from decision makers- Encourages innovative thinking Develop Self and Others- Enhances interpersonal relationships- Models integrity and company values- Seeks out growth and breakthrough opportunities#LI-MV1Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. CAI Benefits:•Comprehensive Health Insurance coverage•24 days of Paid Time Off•ESOP/401K - 15% Company Contribution (US Only)•Company paid Life Insurance•Company paid Long Term DisabilityWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
$61k-84k yearly est. 19d ago
Fully Qualified Navy Validator III (Remote)
Ishpi Information Technologies 4.4
Remote equipment validation engineer job
Ishpi Information Technologies, Inc. (DBA ISHPI) is passionate about providing our customers with technical solutions that satisfy their business needs. Through collaborative interactions with customers, team members, subject matter experts (SMEs), technical leaders, and partners we design practical solutions that solve real problems for major government and business organizations. As a member of our group, you will work with a team focused on delivering innovative business solutions using emerging technologies through proven successful methods. Responsibilities The Fully Qualified Navy Validator III will provide support to the Naval Surface Warfare Command in Philadelphia, PA. Shall assist with the preparation and submission of all RMF A&A and AO packages. All RMF activities shall follow the most current applicabledocuments including DON RMF Process Guide, DoD Instruction 8510.01, and the business rules of cognizant review offices for each package. Shall also produce and maintain RMF artifacts related to the authorization or de-authorization of assigned RMF packages, applications, and systems under the cognizance of NSWCPD. Qualifications Education: Requires a Bachelor's degree in Computer Science from an accredited university. Work Experience: Ten (10) years of professional experience. Experienced in the management of IAT, certification agents and system engineers on the compliance requirements to achieve certification and accreditation IAW the DoD RMF program and the Department of Navy (DON) Chief Information Officer (CIO) IA Policy for PIT Systems. Ten (10) years of support to the DON or DoD, preferably as an IAM, Certification Agent and/or Designated Approval Authority and Certification Authority staff. Certifications: Fully Qualified Navy Validator certificate. IAM Level II certification. Security Clearance: Requires U.S. Citizenship and an active government security clearance. “Ishpi Information Technologies, Inc. is an Equal Opportunity Employer. All qualified candidates will be considered without regard to legally protected characteristics. Expression of Interest: By applying to this job, you are expressing interest in this position and could be considered for other career opportunities where similar skills and requirements have been identified as a match. Should this match be identified, you may be contacted for this and future openings.
$77k-103k yearly est. Auto-Apply 60d+ ago
Equipment Engineer II
Tosoh SMD
Equipment validation engineer job in Grove City, OH
Job Details Experienced Grove City OH - Grove City, OH Full Time Bachelor's Degree None Standard Business Hours EngineeringDescription Tosoh SMD, Inc. is a global leader in semiconductor materials. Our superior products help customers introduce cutting-edge technologies that make our lives easier and move us into the future. Our state-of-the-art manufacturing facility and materials laboratory located in Grove City, OH manages the entire life cycle of our products, including supply chain development, research and development, manufacturing, testing and distribution. Our innovative and devoted team of scientists, engineers, metallurgical experts, manufacturers and managers continuously collaborate and strategize to improve and create new materials for a wide range of customers' semiconductor needs. These products are used in many final applications like automotive, mobile devices, computers, artificial intelligence, 5G networks and industrial automation. As one of over 100 Tosoh Corporation's family of companies our motto is "We Make the Material That Makes Your Devices Work". The Engineer II is responsible for designing, developing, and maintaining equipment/facilities used in the manufacturing processes. This position also provides technical assistance to manufacturing and maintenance personnel to ensure proper operation and maintenance of equipment/facilities. They are responsible for creating design schematics, maintenance schedules, and reports to ensure functional analysis of the equipment/facilities operation and up time for continuous improvement activities. They serve as guides to answer questions, offer insight, and organize responsibilities. This position requires the ability to train and mentor new engineers and maintenance technicians. They follow company policies and ensure team members adhere to all standards and guidelines. Reporting Relationships Engineer II reports to the Equipment Engineering & Maintenance or the Facilities Manager. Major Duties and Responsibilities Design and develop equipment/facilities systems and components for various industrial applications. Conduct research and analysis to identify the best equipment options and technologies. Develop equipment requirements and collaborate with cross-functional teams to ensure equipment designs meet the required specifications and standards. Develop maintenance procedures for equipment/facilities systems and provide training to maintenance personnel. Effectively help maintenance/facilities technicians reduce Mean Time to Repair by championing continuous improvement projects. Evaluate existing equipment/facilities for improvement opportunities, develop proposals for these investments, and present to management for approval. Evaluate and modify existing equipment/facilities systems to improve uptime and improve Mean Time Between Failures. Effectively and successfully manage large capital projects. Provide leadership, expertise, support, and problem-solving techniques on a daily basis while continuing to maintain a high level of productivity and performance. Understands and adheres to all safety requirements. Communicates identified risks to leadership and assists in resolution. Completes all 5S (Sort, Set in Order, Shine, Standardize, and Sustain) standards to maintain a safe, organized, and efficient work environment. Maintains regular and reliable attendance. Contributes to culture through alignment with company values and code of conduct. Maintains a positive attitude, displays enthusiasm for assigned tasks, and communicates effectively and professionally with team members. Other related duties. Education Bachelor's degree in engineering or related field. Skills and Qualifications Strong written and verbal communication skills. Working knowledge of Microsoft programs: Word, Excel, and Outlook. Ability to work collaboratively in a team environment. Understanding of equipment/facilities and systems repair and preventive maintenance. Knowledge and experience with use of tools and test equipment. Working knowledge of robotic systems, including teaching and touching up positions Understanding of servo motors and drives and associated feedback systems. Problem-solving, troubleshooting, and critical thinking skills. Excellent organizational skills and attention to detail. Excellent planning and time-management skills. Must be able to read and understand blueprints including geometric dimensioning and tolerancing. Must be able to develop schematics for equipment design and improvement activities. Ability to train others on maintenance and use of equipment. Must display initiative and innovation. Must demonstrate skill in how to initiate and follow-up on equipment/facilities improvement ideas. Preferred experience is 2 years in related field. Tosoh SMD, Inc. is an Equal Opportunity Employer M/F/Disabled/Veterans
$73k-104k yearly est. 60d+ ago
Validation Engineer, CSV Biopharma (JP13826)
3 Key Consulting
Equipment validation engineer job in New Albany, OH
Business Unit: Ops Digital Technology Innovation Employment Type: Contract Duration: 6+ months with likely extension Rate: $35-40/Hr on W2 with benefits Target start date : 4/28/25 Notes: Onsite New Albany, OH - must be local. Standard hours. 3 Key Consulting is hiring! We are recruiting a CSV Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company. The ideal candidate: 3-5 years of experience in computerized system validation, deviation management, CAPAs, and change tickets within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment. They must hold a Bachelor's or master's degree in computer science, Information Technology, Management Information Systems, Mechanical Engineering, or a related field, with a Master's degree acceptable only if accompanied by at least 3 years of industry experience (no fresh graduates). The role requires onsite work with limited training time, so candidates must be able to hit the ground running. Overqualified candidates (e.g., PhDs or those with 15+ years of experience) may not be the best fit. Strong preference will be given to candidates from a pharmaceutical, biotechnology, or life sciences background. Job Description: Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues. This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of client's Ohio computer systems validation. Top Must Have Skill Sets: Experience with testing tools (ALM, or Kneat or ValGenesis). Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change Management. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211. Understanding of industry standards and best practices for computer system validation such as GAMP 5. Must have experience with deviations IT infrastructure tools is highly preferred but not required (example: backup and restore, disaster recovery) Day to Day Responsibilities: Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc). Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies. Provide support on completion of validation deliverables as required per the project. Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners. Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase. Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards. Support regulatory inspections and internal audits as required. Basic Qualifications: Master degree OR Bachelor degree in Engineering and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience 2. 5+ years relevant experience in computer system validation (E.g: MES, SCADA, Building Management system (BMS, QBAS), Serialization, QC systems). Experience with ALM or Kneat testing tool is plus. 2. Experience with ServiceNow, Track wise (CAPA, Deviations), Veeva document management, CAPA, Deviations, Change Management. 3. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211. 4. Understanding of industry standards and best practices for computer system validation such as GAMP 5. Why is the Position Open? Supplement additional workload on team. Red Flags: No experience on Computer system validation/ validation process. No experience on Deviations. Fresh graduates with no validation or industry experience. Lack of experience with computer system validation or deviation management. No background in Pharma, Biotech, Life Sciences, or relevant IT/Validation roles. Candidates switching from unrelated industries (since training time is limited). Overqualified candidates with 15-20+ years of experience and/or candidates with PhDs. Interview Process: WebEx or onsite. Interview rounds: Typically 2 rounds (with hiring manager and his manager), but could extend to 3 rounds if needed We invite qualified candidates to send your resume to *****************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team
$35-40 hourly Easy Apply 60d+ ago
Packaging Equipment Engineer
KDC-Columbus 3.5
Equipment validation engineer job in New Albany, OH
** The Packaging Equipment Engineer plans and directs activities to optimize filling line performance and drive continuous improvement plans and plays a key role in equipment selection for new projects and cost savings initiatives. * * **Essential Duties and Responsibilities: ** Drives continuous improvements throughout filling and packaging operations. Supports manufacturing operations by troubleshooting and process improvement. Develops and implements processes and systems to measure line performance and prioritize improvement areas to reduce downtime and small stops and improve quality and throughput. Manages the development and implementation of equipment for new products, processes, and capacity expansion plans. Leads equipment and process qualification activities for new equipment and processes. Assists with all project proposals and cost estimates as well as gathers all project related quotes. Provides costing estimates for projects and products. Provides leadership and training in continuous improvement methodologies (Lean, DMAIC, etc) and coaches employees in the use of these tools. Tracks improvement project and submits weekly summaries detailing status of each project. Participates in loss analysis studies. Uses 3D printing and 3D scanning technologies to improve cost and reactivity. Ensures that capital projects are on budget. Provides training to line leads, operators, and mechanics as needed in key SOPs and improvement methodologies. Supports Health & Safety programs and cGMP initiatives. Assists with preliminary budgetary information, Standard Operating Procedures (SOPs), Work Instructions (WIs), and other paperwork according to established company policy. Maintains confidentiality of sensitive and confidential information. Exhibits regular and predictable attendance and works outside of the normal schedule as needed due to workplace demands (e.g. supporting off-shifts). Performs other related duties as required. Minimum Qualifications: Bachelor of Science degree in an engineering discipline or equivalent; preferably Mechanical Engineering or Industrial Engineering. In lieu of a degree, equivalent years of experience will be considered. Minimum 7 years of experience in a production environment (preferably FDA regulated) with both high speed and agile filling and packaging systems. Knowledge, Skills & Abilities Knowledge of: Microsoft Office Suite; FDA Good Manufacturing Practices and OSHA Safety Requirements; variety of liquid filling/packaging practices and procedures; driving OEE improvement; Lean Manufacturing; AutoCAD; Solidworks; and experience with 3D printing and scanning. Skills in solving problems; prioritizing work to ensure deadlines are met; problem solving, analytical and technical skills, strong communication, interpersonal, team building, and organization. Ability to: manage multiple and competing priorities; resolve difficult situations with no clear direction; adapt to change; develop and maintain good working relationships; develop and maintain processes and workflows; be detail-oriented; communicate effectively both verbally and in writing to a diverse group of individuals; present information to large and small groups; be organized and work quickly and efficiently with short deadlines; multi-task; read, comprehend and follow written and verbal instructions, including SOPs; work independently and as part of a team; operate a computer; wear required PPE as needed when walking through the facility; ability to interact effectively with all levels of organization. Other functions, skills and abilities may apply. You should be proficient in: Continuous Improvement Troubleshooting Skills FDA Regulations Standard Operating Procedures (SOPs) Lean Manufacturing Principles Experience in a Manufacturing Environment Root Cause Analysis Machines & technologies you'll use: CAD Software
$68k-93k yearly est. 1d ago
Equipment Engineer
Actalent
Equipment validation engineer job in East Liberty, OH
This role involves working with a real-time logistics provider, supporting multiple facilities in the Ohio area. The focus is on providing a wide variety of automotive parts and sub-assembled parts to manufacturing facilities. Responsibilities * Identify, justify, source, and implement solutions within a material handling environment. * Develop and design equipment to support assembly operations. * Monitor and improve current processes and equipment. * Identify and troubleshoot process, electrical, and mechanical issues for production departments. * Create, update, and integrate mechanical drawings in AutoCAD. * Manage projects including preparing technical requirements and documents for capital justification. * Schedule and conduct technical project reviews with the management team. * Create and manage schedules and budgets for capital and expense projects. * Assist in defining company strategies for automation and equipment-related projects. * Manage various contractors during repairs and projects. * Create procedures for contractors' requirements. * Create process flows and corporate communications for preparedness and response to changes. * Document requirements and scopes of work for capital projects and strategies. Essential Skills * PLC Troubleshooting Experience * Electrical Automation experience * Robotics exposure * Associates or Bachelors Degree in Engineering or a related technical field * Electrical design and AutoCAD proficiency Additional Skills & Qualifications * Basic understanding of PLC systems and system controls * Understanding of vision systems (training provided) * Knowledge of DC torque equipment and management * Strong PC skills with Microsoft Office Suite and AutoCAD * Excellent communication skills Work Environment This position is based in a manufacturing and distribution environment, operating on a 2nd shift from 4 PM to 12:30 AM. Overtime is available for associates. The role offers long-term opportunities, with a potential pathway to direct hire and advancement within the organization. Job Type & Location This is a Contract position based out of East Liberty, Ohio. Job Type & Location This is a Contract position based out of East Liberty, OH. Pay and Benefits The pay range for this position is $30.00 - $32.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in East Liberty,OH. Application Deadline This position is anticipated to close on Dec 4, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$30-32 hourly 13d ago
Validation Engineer
Syner-G Biopharma Group
Remote equipment validation engineer job
: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit *********************** POSITION OVERVIEW: We are seeking a hands-on Validation Engineer with a strong background in mechanical or manufacturing engineering, who brings expertise in automated manufacturing environments, preferably within the life sciences or biopharma industry. This role combines engineering document reviews, equipment startup support, and process/manufacturing engineering with project management and cross-functional communication responsibilities. The ideal candidate will have experience in line layouts, fixture design, and 3D printing, with a preference for knowledge of filling and capping equipment. While this is not a controls engineering role, familiarity with PLCs and HMIs is required. The role also involves managing smaller projects and collaborating across teams to ensure successful execution in GMP-regulated environments. Proficiency in AutoCAD and SolidWorks is essential. WORK LOCATION: Travel to client sites may be required up to 100%, depending on project demands and client expectations. KEY RESPONISIBILITIES: Perform equipment qualifications including Commissioning, IQ, OQ, and PQ. Provide hands-on engineering support during equipment startup and validation activities. Conduct engineering document reviews and contribute to process improvement initiatives. Write, review, approve, and execute validation protocols and reports. Lead and mentor a small team of CQV engineers. Collaborate with scientists, technicians, engineers, and project managers to deliver validated equipment and facilities. Ensure validation programs meet GMP, FDA, and ISO standards. Support design and execution of verification tests and validation strategies. Coordinate with cross-functional teams and vendors to meet project milestones. Contribute to layout planning and fixture design, leveraging 3D printing where applicable. Communicate effectively across disciplines to define requirements and deliver solutions. QUALIFICATIONS & REQUIREMENTS: Education : Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related life science field. Technical Experience : 5-7 years of experience in biotech, pharmaceutical, or medical device industries. Strong understanding of GMP, FDA regulations, FMEA, and risk analysis. Experience with validation disciplines including Equipment, CSV, Method, and Process. Skilled in protocol generation and validation of automated production systems. Proficient in AutoCAD and SolidWorks. Familiarity with PLCs, HMIs, and automated manufacturing systems. Experience with high-speed fill-finish lines is a plus. Skills and Abilities : Strong leadership and project management skills. Excellent communication and stakeholder engagement across functions. Ability to manage vendors and contractors effectively. Hands-on approach to engineering and problem-solving. Willingness to travel up to 100% for client site projects. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements 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. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.
$73k-95k yearly est. Auto-Apply 14d ago

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Updated December 4, 2025

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