- Abbott (Columbus, OH)
- …and implementation of the CAPA management system + Develop, execute and review FDA validation protocols and related documentation in accordance with procedures ... meet Division standards. **WHAT YOU'LL DO** + As a Validation Engineer, you'll have the chance to create and...concerns in a timely manner + Comply to all FDA policies and standards + Use M-Files to house… more
- Unither Pharmaceuticals (Rochester, NY)
- …change and adapt project scope creep and change in timelines. Understanding of FDA requirements for validation . The ability to analyze and interpret data. ... Computer Systems Validation Specialist Who we are? We are a...mitigation methods. Develops, writes, and executes qualification protocols ensuring FDA 21 CFR part 11 and Annex 11 compliance… more
- J&J Family of Companies (Danvers, MA)
- …robotics, PLC-controlled systems). + Serve as the subject matter expert (SME) for process validation , ensuring alignment with FDA 21 CFR Part 820, ISO 13485, and ... and automated assembly processes. + Strong working knowledge of FDA , ISO, and GHTF validation requirements, including...working knowledge of FDA , ISO, and GHTF validation requirements, including IQ/OQ/PQ frameworks. + Proven ability to… more
- Actalent (Winston Salem, NC)
- …, systems engineering. + Understanding of full compliance for lab instrumentation, validation protocols, FDA compliance, audit, lab equipment, IQ, OQ, PQ. ... Validation Engineer Job Description This validation Engineer...+ Audit and FDA experience. Additional Skills & Qualifications + Education in Engineering,… more
- ManpowerGroup (Groton, CT)
- …biotech, or regulated manufacturing environment. + Strong understanding of cGMPs, FDA regulations, and industry validation practices (eg, ASTM E2500, ... Pharmaceutical and Life Sciences industry, is seeking a CQV Validation Engineer to join their team. As a CQV... Engineer to join their team. As a CQV Validation Engineer, you will be part of the Quality… more
- Teva Pharmaceuticals (West Chester, PA)
- …in life science or engineering PREFERRED QUALIFICATIONS: + Knowledge of validation and quality compliance (cGMP/ICH/ FDA /USP/EP policies/guidelines) + ... Validation Engineer I Date: Jul 25, 2025 Location:...people to make a difference with. **The opportunity** The Validation Engineer I role is responsible for assisting in… more
- VTI Life Sciences (Raleigh, NC)
- …and future site regulatory inspections + SME for presentation of cleaning validation to Regulatory ( FDA ), internal and external auditors. + Identify ... in the Life Sciences industry. We are looking for up to 10 Cleaning Validation Engineers to work onsite at our client's pharmaceutical manufacturing facility in the… more
- Abbott (Lake Forest, IL)
- …CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer System Assurance + ... mothers, female executives, and scientists. **The Opportunity** This position **Software Validation and Cybersecurity Specialist** works out of our Lake Forest, IL… more
- Bristol Myers Squibb (Warren, NJ)
- …or Science related discipline. + Minimum of 5 years of experience in FDA -regulated industry ( validation preferred), or 3 years and an advanced degree. ... The incumbent's focus is support of small to medium size validation projects, such as new product introduction, facilities/utilities upgrade and modification,… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …and immunology. You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory ... We are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized...11, GAMP 5, and Annex 11. **As a Senior Validation Specialist, a typical day might include:** + Planning… more