Commissioning and Qualification (C&Q) Manager

Responsibilities

• Lead, mentor, and manage a team of C&Q engineers and specialists.
• Oversee workload distribution and resource planning to support multiple concurrent projects.
• Support staff development through training, performance feedback, and technical guidance, establishing performance metrics and providing ongoing training aligned with regulatory updates and best practice standards.
• Oversee departmental budget preparation and monitor financial performance, including cost forecasting and variance analysis, ensuring C&Q projects remain within scope and budget.
• Manage risk identification and mitigation strategies related to C&Q scope and integrate safety observations into corrective actions, fostering a zero-incident work culture.
• Maintain strong team morale and foster a collaborative work environment.
• Oversee the planning, execution, and documentation of commissioning and qualification activities for equipment, utilities, and building systems.
• Provide expert guidance on commissioning and qualification methodologies, including IQ/OQ/PQ, FAT/SAT, and risk-based approaches.
• Ensure that all project deliverables meet client expectations, industry standards, and regulatory requirements.
• Serve as a technical escalation point for project teams.
• Build and maintain strong client relationships, ensuring high satisfaction and repeat business.
• Understand client needs and propose appropriate solutions or service offerings.

Qualifications

• Demonstrated experience in commissioning and qualification management, including leadership responsibilities managing teams.
• Strong understanding of building systems, utilities (HVAC, WFI, clean steam, compressed air, etc.), and process equipment.
• Comprehensive knowledge of cGMP regulations, FDA/EMA expectations, GAMP principles, and industry best practices.
• Demonstrated ability to manage multiple projects and deadlines in a dynamic consulting environment.
• Proficient in reviewing, interpreting, and validating complex engineering documentation including IQ/OQ/PQ protocols, FAT/SAT reports, and design specifications.
• Demonstrated success in leadership roles emphasizing mentorship, staff development, and cross-functional collaboration in complex project delivery.
• Experience developing and managing departmental budgets and leading strategic planning initiatives related to commissioning services.
• Skilled in Microsoft 365 suite including document management and collaboration tools; experience with commissioning-specific software is an advantage.
• Bachelor’s degree in Engineering, Architecture, or a related technical field; active Professional Engineer (PE) license or equivalent certification preferred where responsible charge applies.