C&Q Engineer - Fill&Finish
We are currently seeking a highly skilled and experienced Commissioning & Qualification (C&Q) Consultant with specialized expertise in Fill & Finish operations to support a critical pharmaceutical or biotech project. This role is ideal for professionals who have a strong background in sterile manufacturing environments and are passionate about ensuring equipment and systems meet the highest standards of compliance and performance.
As a C&Q Consultant, you will be responsible for leading and executing commissioning and qualification activities for a range of Fill & Finish equipment and systems. These may include vial and syringe filling lines, isolators, capping machines, depyrogenation tunnels, and visual inspection systems. Your work will be instrumental in ensuring that all equipment and processes are validated in accordance with GMP, GAMP 5, and global regulatory requirements, including FDA and EMA standards.
You will collaborate closely with cross-functional teams including engineering, validation, quality assurance, and manufacturing to ensure seamless integration of new systems and upgrades. Your ability to manage documentation, drive compliance, and provide technical leadership will be key to the success of the project.
Key Responsibilities:
*Lead and execute C&Q activities for Fill & Finish equipment such as vial/syringe filling lines, isolators, capping machines, and inspection systems.
*Author and review C&Q documentation including URS, DQ, IQ, OQ, and PQ protocols and reports.
*Ensure all systems are qualified in compliance with GMP, GAMP 5, and applicable regulatory guidelines.
*Collaborate with engineering, QA, validation, and manufacturing teams to support project execution.
*Conduct risk assessments, manage deviations, and support change control processes.
*Provide technical guidance and mentorship to junior staff and stakeholders.
Requirements:
*Proven experience in C&Q within sterile Fill & Finish environments.
*Strong understanding of GMP, GAMP 5, and regulatory expectations for pharmaceutical manufacturing.
*Hands-on experience with Fill & Finish equipment and clean utilities.
*Excellent technical writing and communication skills.
*Ability to work independently and manage multiple priorities in a dynamic setting.
*French and English speaker
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