Commissioning & Qualification Lead
Intellectt Inc
Position Summary:
We are seeking an experienced Commissioning & Qualification (C&Q) Lead to oversee commissioning, qualification, and startup activities for a major greenfield pharmaceutical manufacturing facility. This leadership role is responsible for executing the full C&Q lifecycle, ensuring GMP compliance, managing cross-functional teams, and supporting successful operational readiness and system handover.
Key Responsibilities:
- Lead commissioning and qualification activities for an assigned project area throughout the full project lifecycle.
- Develop and execute C&Q strategies, schedules, and execution plans aligned with overall project objectives.
- Coordinate Mechanical Completion (MC), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, startup, qualification, and system turnover activities.
- Oversee pre-commissioning activities including utility startup, instrument calibration, automation configuration, equipment preparation, and functional testing.
- Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities in collaboration with Validation and Quality teams.
- Ensure compliance with GMP, FDA, ISPE, GAMP, and internal quality standards.
- Collaborate with Engineering, Construction, Manufacturing, Automation, Validation, Quality, and Operations teams to ensure seamless project execution.
- Monitor project schedules, critical path activities, KPIs, risks, and resource requirements while supporting change management processes.
- Drive issue resolution, punch list closure, and timely completion of commissioning and qualification documentation.
- Coordinate operational readiness, system turnover, and transition to manufacturing operations.
- Promote a strong safety culture by ensuring compliance with site safety standards, Lockout/Tagout (LOTO) procedures, and industry best practices.
Preferred Qualifications:
- Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related discipline).
- 8–15+ years of experience in Commissioning, Qualification, Validation, or Capital Projects within pharmaceutical, biotechnology, or other FDA-regulated manufacturing environments.
- Demonstrated leadership experience on large-scale CAPEX, greenfield, or brownfield projects.
- Strong knowledge of GMP, FDA regulations, ISPE guidelines, and the complete C&Q lifecycle.
- Experience with clean utilities, process equipment, automation systems, and manufacturing startup activities.
- Proven ability to lead multidisciplinary teams, manage stakeholders, and deliver complex projects on schedule and within compliance requirements.
Vacancy posted 17 hours ago
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