C&Q Lead – Global Engineering

C&Q Lead – Global Engineering

Purpose

The C&Q Lead will support the C&Q Manager in planning and executing commissioning and qualification activities for facilities, utilities, process equipment, and related systems within a pharmaceutical capital engineering project.

The role will provide day-to-day coordination and technical leadership for assigned C&Q activities, ensuring that systems are commissioned and qualified safely, on schedule, and in accordance with approved project requirements, company procedures, GMP expectations, and applicable industry standards.

The position may support aseptic fill-finish, bulk drug substance, or other pharmaceutical manufacturing projects.

Key Responsibilities

• Lead and coordinate day-to-day C&Q activities for assigned systems and project areas.
• Coordinate C&Q engineers, subject matter experts, contractors, and equipment vendors.
• Support the C&Q Manager in developing and maintaining C&Q plans, schedules, resource requirements, and deliverables.
• Ensure C&Q activities are incorporated into the integrated project schedule and delivered in line with project milestones.
• Apply risk-based commissioning and qualification principles to assigned systems.
• Coordinate the preparation, review, and execution of commissioning tests, qualification protocols, reports, and turnover documentation.
• Review C&Q documentation for completeness, accuracy, traceability, and compliance.
• Support the investigation and resolution of deviations, non-conformances, test failures, punch-list items, and other C&Q issues.
• Coordinate with engineering, construction, quality, operations, maintenance, automation, project controls, and external vendors.
• Provide regular updates on C&Q progress, risks, issues, and schedule performance.
• Support factory acceptance testing, site acceptance testing, system turnover, operational readiness, and project handover activities.
• Support audits, inspections, and project readiness reviews as required.
• Ensure all activities are performed in accordance with applicable health, safety, environmental, quality, and GMP requirements.

Required Qualifications and Experience

• Bachelor’s degree in engineering, science, life sciences, or a related technical discipline.
• Typically, 7+ years of experience in commissioning, qualification, validation, engineering, or related discipline within the pharmaceutical, biotechnology, medical device, or other regulated industry.
• Demonstrated experience coordinating or leading C&Q activities on pharmaceutical capital projects.
• Experience with one or more of the following: facilities, clean utilities, process utilities, HVAC, water systems, process equipment, manufacturing systems, or laboratory systems.
• Strong working knowledge of GMP requirements and risk-based C&Q principles.
• Familiarity with FDA expectations, ICH Q8/Q9/Q10, ISPE guidance, Annex 1, ISO Standards and applicable industry standards.
• Experience developing, reviewing, and executing C&Q documentation and protocols.
• Experience supporting deviations, change controls, non-conformances, and corrective actions.
• Experience working with engineering contractors, equipment vendors, construction teams, and site operations.
• Strong communication, organizational, and problem-solving skills.
• Ability to manage multiple priorities and work effectively in a fast-paced project environment.

Preferred Experience

• Aseptic fill-finish and/or bulk drug substance manufacturing projects.
• Cleanrooms, HVAC, process gases, purified water, WFI, clean steam, or other critical utilities.
• Automation, computerized systems, building management systems, or manufacturing execution systems.
• Factory acceptance testing, site acceptance testing, system turnover, and operational readiness.
• Previous experience working as a contractor or within a large-scale pharmaceutical capital program.

Pay: $100,000.00 - $140,000.00 per year

Work Location: In person