- C&Q Specialist - Facilities & Construction
Position Summary
The C&Q Specialist will provide Commissioning and Qualification support for facility, utility, and construction-related systems within a biotech/pharmaceutical manufacturing environment. The role will support project execution from construction completion through commissioning, qualification, and turnover to operations.
Key Responsibilities
- Support commissioning and qualification activities for new and modified facilities and utilities.
- Review construction drawings, P&IDs, equipment specifications, submittals, and vendor documentation.
- Support field walkdowns, system inspections, and construction completion verification.
- Develop and/or execute C&Q documentation, including:
- Commissioning protocols
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Turnover packages
- Punch lists and discrepancy documentation
- Verify installation against approved drawings, specifications, and design requirements.
- Coordinate C&Q activities with Engineering, Construction, Quality, Operations, and contractors.
- Support system turnover from Construction to Commissioning/Qualification and Operations.
- Identify, document, and follow up on construction or qualification issues.
- Support change controls, deviations, and corrective actions as required.
- Ensure activities are performed in accordance with GMP requirements, site procedures, and applicable industry standards.
Typical Systems
- HVAC systems
- Cleanrooms and controlled environments
- Process and facility utilities
- Chilled water and hot water systems
- Compressed air and gases
- Plumbing and drainage systems
- Electrical and building support systems
- Facility monitoring and associated instrumentation
Qualifications
- Bachelor's degree in Engineering, Science, Construction Management, or related technical discipline preferred.
- 3-5 years of experience in commissioning, qualification, engineering, construction, or facilities within pharmaceutical, biotechnology, or another regulated industry.
- Experience reviewing engineering drawings and construction documentation.
- Knowledge of GMP practices and C&Q documentation.
- Strong field coordination, documentation, communication, and problem-solving skills.
- Ability to work effectively with multidisciplinary project teams and contractors.
- Preferred Experience
- Experience supporting biotech or pharmaceutical facility construction projects.
- Familiarity with system turnover, mechanical completion, punch-list management, and startup activities.
- Experience executing IQ/OQ protocols for facility and utility systems.
