We are looking to speak with an experienced CQV Engineer to join a Pharmaceutical client of ours. This role will be responsible for support project scoping, commissioning, qualification, validation and start-up operations. This is a 12 month contract, fully onsite.
- Experience in commissioning and qualification (C&Q) of process equipment and utilities (both preferred).
- Knowledge of vendor documentation, both onsite and at vendor locations.
- Full experience in the C&Q process, from URS to QSR.
- Ability to manage multiple projects simultaneously.
- Experience with deviations and discrepancies.
Initial Focus:
- Complete qualification training and familiarize with SOPs.
- Buddy system for onboarding support.
Key Responsibilities:
- Generate, review, and execute C&Q documentation for the company and vendors.
- Collaborate with system owners, QA, and stakeholders.
- Oversee and coordinate all C&Q activities for various systems, ensuring compliance with GMP and safety standards.
- Manage C&Q schedules, track status, report risks/issues, and coordinate daily meetings.
- Provide technical support for investigations and system design.
- Assist in the development of URS and QRAES.
Education/Experience:
- 6+ years in Engineering or C&Q management.
- Technical qualification in Engineering or equivalent.
- Extensive C&Q experience in pharmaceutical/biotech projects.
- Strong knowledge of GMP, safety, and environmental regulations.
- Excellent communication, leadership, and collaboration skills.
- Familiarity with paperless validation systems.
