CQ Engineer

Position Summary:

We are seeking an experienced Commissioning and Qualification Engineer (CQ Engineer) to join our dynamic team on a milestone project—the construction and operation of the largest chemical production site for Active Pharmaceutical Ingredients (APIs). This individual will be responsible for leading the commissioning, qualification, and validation activities to ensure regulatory compliance and successful start up of manufacturing operations.

Key Responsibilities:

• Lead end-to-end CQ activities for new API manufacturing facilities, utilities, and equipment.
• Develop, review, and execute CQ protocols including IQ/OQ/PQ (Installation, Operational, Performance Qualification).
• Collaborate with cross-functional teams (engineering, construction, quality, operations) to ensure smooth project execution.
• Oversee and coordinate third-party vendors and contractors involved in commissioning/qualification tasks.
• Interpret and apply current Good Manufacturing Practices (cGMP), GAMP, relevant regulations (ISO, FDA, EMA), and industry guidelines.
• Troubleshoot complex engineering and validation issues as they arise.
• Prepare and present documentation, operational readiness reports, deviations, and change controls in line with project and regulatory requirements.
• Mentor and provide technical guidance to junior engineers and CQ technicians.
• Manage timelines, workflows, and priorities to meet critical project milestones.

Essential Qualifications & Experience:

• Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, or related technical discipline.
• 10+ Years hands-on experience in Commissioning, Qualification, and Validation within large-scale pharmaceutical, API, or chemical manufacturing environments.
• In-depth knowledge of cGMP, FDA, EMA, GAMP, and regulatory requirements for API production facilities.
• Proven leadership in complex, multi-phase greenfield/brownfield CQ projects.
• Expertise in risk management practices (e.g., risk-based commissioning and qualification).
• Strong communication, reporting, and stakeholder management skills.
• High-level problem-solving and troubleshooting abilities.