Are you an experienced Commissioning & Qualification Engineer looking to take ownership of projects, equipment, and documentation? We're seeking a C&Q Engineer to support capital projects, ensuring compliance with GMP and Quality requirements while maintaining safety and schedule adherence.
Key Responsibilities:
- Lead Commissioning & Qualification activities for Clean Utility Systems.
- Develop and execute C&Q documentation (C&Q Plan, FAT/SAT, IQ/OQ/PQ, Summary Reports).
- Manage daily C&Q coordination, tracking status, and addressing risks/issues.
- Ensure safe and efficient startup of equipment/utilities.
- Provide technical support for investigations and system design.
Qualifications & Experience:
- 6+ years in Engineering or C&Q management, preferably in Pharma/Biotech.
- Technical degree in Engineering or related field.
- Strong knowledge of GMP, safety, and regulatory compliance.
- Experience with risk-based commissioning and qualification strategies.
- Excellent leadership, communication, and stakeholder management skills.
- Familiarity with paperless validation systems is a plus.
