Validation Engineer
7 days ago
Job Description:
We are looking for an experienced Validation Engineer with a strong background in sterile manufacturing environments. The ideal candidate should have hands-on experience in performing and documenting validation activities, ensuring compliance with cGMP and regulatory requirements.
Key Responsibilities:
- Execute and document validation activities including:
- Equipment Qualification (IQ/OQ/PQ)
- Autoclave Qualification
- HVAC Qualification
- Smoke Studies
- Cleaning Validation
- Prepare and review validation protocols and reports.
- Coordinate with cross-functional teams (Production, Quality Assurance, Engineering) to ensure validation readiness.
- Ensure compliance with current regulatory guidelines (USFDA, EU GMP, WHO).
- Conduct periodic re-validation and maintain validation master plan documentation.
- Support audit readiness and respond to audit observations related to validation activities.
Required Skills & Experience:
- Experience: 4 – 8 years in validation within a sterile/aseptic manufacturing setup.
- Qualification: B.E/B.Tech in Mechanical, Electrical, Instrumentation, or Chemical Engineering / M.Sc. in related discipline.
- Technical Skills: Knowledge of cGMP, equipment qualification procedures, and validation documentation practices.
- Soft Skills: Strong analytical, documentation, and communication skills.
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