C&Q Engineer
We are seeking an experienced Commissioning & Qualification (C&Q) Engineer to support ongoing qualification and validation activities within a GMP-regulated pharmaceutical manufacturing environment. The successful candidate will play a key role in coordinating qualification documentation, executing qualification activities, and ensuring alignment between Engineering and Quality teams.
This position is strongly focused on the engineering side of qualification, providing technical leadership and structure to qualification activities currently managed by project teams.
Responsibilities
- Develop, review, and execute qualification documentation and protocols.
- Lead and support FAT, SAT, IQ and OQ activities for equipment and systems.
- Coordinate qualification deliverables with Engineering, QA and Project Management teams.
- Track qualification progress and provide dashboard reporting on project status.
- Drive technical discussions and ensure timely resolution of qualification-related issues.
- Review documentation packages and identify missing GMP and qualification requirements.
- Act as the focal point for qualification activities, ensuring clear communication between stakeholders.
- Support document management, protocol execution, deviations and follow-up actions.
- Contribute to qualification planning and future resource requirements for upcoming projects.
- Ensure all activities are performed in accordance with GMP requirements and internal procedures.
Profile Required
- Minimum 5 years of experience in Commissioning, Qualification and Validation within the pharmaceutical, biotechnology or life sciences industry.
- Strong expertise in FAT, SAT, IQ and OQ execution and documentation.
- Proven experience developing and managing qualification protocols.
- Good understanding of GMP-regulated environments.
- Engineering background with a practical and technical approach to qualification activities.
- Experience working with multidisciplinary teams including Engineering, QA and Project Management.
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