An exciting opportunity for an Engineering Specialist (Validation) to join a cGMP regulatory environment. The role supports various validation activities across sterilization, cleaning, isolator systems, controlled temperature units, filter validation, and container closure integrity validation.
Key Responsibilities:
- Author, review, and execute validation protocols and cycle development studies.
- Manage change controls, deviations, and risk assessments to ensure compliance.
- Provide technical expertise in troubleshooting and root cause analysis of system failures.
- Collaborate cross-functionally with Production, Maintenance, and Quality teams.
- Support regulatory audits and compliance with GMP, global policies, and industry standards.
- Lead and contribute to continuous improvement initiatives using Lean Six Sigma methodologies.
Qualifications & Skills:
- Degree in Engineering, Pharmaceutical, Biological, or Chemical sciences.
- Experience in GMP manufacturing with a strong background in equipment and process validation.
- Knowledge of thermal mapping, CTU qualification, autoclave/SIP validation, isolator qualification, and cleaning validation.
- Strong problem-solving, project management, and data analysis skills.
- Proficiency in Microsoft Office, automation systems (DeltaV), and process monitoring tools (Pi System) is desirable.
The successful candidate will work both independently and cross-functionally, driving validation excellence in a fast-paced, regulated environment.
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