Process Validation Engineer
E-Solutions
Job: Process Validation Engineer Work location: Northridge, CA - onsite Job Summary:
- We are seeking a Process Validation Engineer to develop, execute, and maintain validation activities for manufacturing processes, equipment, and systems. The ideal candidate will ensure compliance with regulatory requirements and support continuous improvement initiatives to maintain product quality and process reliability.
- Plan, execute, and document process validation activities.
- Develop and review validation protocols, reports, and related documentation.
- Perform IQ, OQ, and PQ for manufacturing equipment and processes.
- Analyze validation data and identify process improvement opportunities.
- Collaborate with Production, Quality Assurance, Engineering, and Regulatory teams.
- Investigate deviations, non-conformances, and CAPA activities related to validation.
- Ensure compliance with GMP, FDA, ISO, and other applicable regulations.
- Support technology transfers and new product introductions.
- Maintain validation master plans and validation schedules.
- Participate in audits and inspections as a validation subject matter expert.
- Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, or related field.
- 2-8 years of experience in process validation within pharmaceutical, medical device, biotech, or manufacturing industries.
- Knowledge of GMP, FDA regulations, and validation lifecycle concepts.
- Experience with IQ/OQ/PQ execution and documentation.
- Strong analytical, problem-solving, and communication skills
Vacancy posted 3 days ago
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