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Validation Engineer, CSV Biopharma
3 Key Consulting
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New Albany, OH, 43054
... 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 ... - Jan 09
Engineer, Pharmaceutical Packaging and Validation
3 Key Consulting
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New Albany, OH, 43054
... Knowledge of data analysis, CGMP documentation, and Packaging Equipment Validation. Must be motivated, and with some training, be able to work with minimum supervision in a GMP environment. Candidate must be a team player, process-driven and able to ... - Jan 09
Validation Engineer
PSC Biotech
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Clinton Township, OH, 43224
... 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, ... - Jan 19
Senior Packaging Validation Engineer, Biotech GMP Final Drug Product
3 Key Consulting
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New Albany, OH, 43054
... The Senior Validation Engineer position reports into the Sr. Manager of Validation. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations ... - Jan 19
Validation Engineer
Katalyst Healthcares & Life Sciences
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Dublin, OH, 43016
... Roles & Responsibilities : Execute equipment qualification and validation activities (IQ/OQ/PQ) Support utility and facility qualification efforts Ensure compliance with GMP, GAMP 5, and 21 CFR Part 11 requirements Apply and interpret US FDA and EU ... - Jan 24
Plant Hygienist
Astrix Inc
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New Albany, OH, 43054
... sanitization (C&S) validation protocols for all manufacturing processes. Develop and manage the Site Cleaning & Sanitization Master Plan, ensuring consistency across sanitation processes. Optimize cleaning recipes in collaboration with R&D, Plant ... - Jan 24
Validation Engineer
Commissioning Agents Inc.
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Columbus, OH, 43216
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... - Jan 09
GMP Equipment Monitoring Technician, 3rd Shift
Forge Biologics
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Clinton Township, OH, 43224
... Ensure all equipment monitoring and maintenance activities comply with GMP, QC, and regulatory requirements. Update regulatory changes and implement necessary adjustments to equipment monitoring protocols. Document calibration and validation ... - Jan 19
Engineer Senior, Process Development GMP Packaging
3 Key Consulting
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New Albany, OH, 43054
... Lead commissioning, qualification, and validation (CQV) of GMP equipment. Own and maintain the site master validation plan. Operational Excellence: Analyze, design, and implement manufacturing/business process improvements. Drive productivity, ... - Jan 13
Associate Director, Manufacturing (GMP)
Amplify Bio
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New Albany, OH, 43054
... for leading and overseeing the manufacturing operations within a GMP-compliant facility specializing in advanced therapies. ... new cell and gene therapy products from development to manufacturing, ensuring successful scale-up and process validation. ... - Jan 16