Position Overview:
The CQ Lead Engineer is responsible for the leadership and coordination of commissioning and qualification activities for advanced pharmaceutical equipment, primarily focusing on Filling Lines, Lyophilisers, and Labellers. This role is pivotal in ensuring that all systems are installed, commissioned, and qualified according to regulatory standards and project requirements. The CQ Lead Engineer also supports project management functions, ensuring timely delivery and compliance with cGMP.
Key Responsibilities:
Lead and coordinate the commissioning and qualification processes for filling lines, lyophilisers, and labellers.
Manage cross-functional teams including engineering, validation, operations, and vendors.
Oversee the development, execution, and review of CQ documentation including protocols, reports, risk assessments (IQ/OQ/PQ).
Develop and maintain project plans, schedules, and budgets relating to CQ activities.
Ensure alignment and compliance with relevant regulatory standards (e.g., FDA, EudraLex, GAMP, cGMP).
Liaise with equipment suppliers and contractors for technical documentation, FAT, SAT, and troubleshooting.
Drive issue resolution and continuous improvement during CQ phases.
Deliver regular status reports, risk registers, and presentations to project stakeholders and management.
Support and supervise site acceptance testing, commissioning, and qualification efforts.
Train and mentor junior engineers and technical staff in CQ procedures and best practices.
Maintain project documentation and ensure all changes are managed per documentation control policies.
Qualifications & Experience:
Bachelor’s degree in Engineering discipline (Mechanical, Chemical, Electrical, or related field) required.
Minimum of 7 years Commissioning & Qualification (CQ) experience in pharmaceutical or biotech environments is essential.
Proven hands‑on experience with filling lines, lyophilisers, and labellers (installation, CQ, troubleshooting).
Demonstrated project management experience; PMP certification or relevant training preferred.
Thorough understanding and practical knowledge of regulatory compliance for pharmaceutical equipment commissioning.
Experience managing vendors, coordinating cross-functional teams, and driving projects to completion on time and within budget.
Strong problem‑solving and communication skills.
Ability to work collaboratively and influence stakeholders at all levels.
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