Process Validation Engineer

Process Validation Engineer





Key Responsibilities:


- Review validation plans, process documentation, risk assessments, batch records, SOPs, and prior qualification packages to identify gaps.
- Develop and revise process-validation and PPQ protocols, sampling plans, acceptance criteria, and traceability documentation.
- Coordinate protocol readiness with Manufacturing, Quality, Engineering, Automation, and Laboratory teams.
- Execute process-validation and PPQ activities on the manufacturing floor according to approved protocols.
- Collect and review process data, test results, equipment parameters, and supporting records to verify acceptance criteria.
- Ensure validation activities are properly documented and compliant with GMP and regulatory requirements.


Requirements / Qualifications:


- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Chemistry, or a related technical field.
- 5+ years of experience in process validation, process engineering, or validation within a pharmaceutical or biopharmaceutical manufacturing environment.
- Strong experience developing and executing process-validation and PPQ protocols.
- Hands-on experience with process qualification, sampling plans, risk assessments, and validation documentation.
- Knowledge of cGMP, FDA regulations, and pharmaceutical manufacturing practices.
- Experience working cross-functionally with Manufacturing, Quality, Engineering, Automation, and Laboratory teams.
- Strong technical writing, documentation, data-analysis, and problem-solving skills.