Lead QA Technician

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher Scientific Inc. offers an exciting opportunity to join a top-tier Manufacturing team at our Swindon UK site a leading facility specializing in sterile pharmaceutical production including liquids and lyophilized products for clinical and commercial use. The Swindon site features state-of-the-art filling lines lyophilizers and advanced packaging capabilities and is fully compliant with international regulatory standards such as MHRA and FDA. As part of our global network the site plays a critical role in delivering vaccines and life-saving therapies to patients worldwide.

This is a hands-on high-impact role for candidates with at least 3 years of experience in sterile manufacturing or a related pharmaceutical environment. You will ensure high-quality production proactively identify and resolve operational issues and help drive continuous improvement in a fast-paced innovative setting.

Responsibilities:

• Provide quality assurance oversight for operational tasks within the assigned team.

• Review sterilization cycles FMS systems and other key cleanroom controls.

• Manage logbooks and support area control compliance.

• Perform online batch record review and close batches with LIMS & SAP transactions and C of A generation.

• Review update and maintain Standard Operating Procedures and Controlled Documents.

• Supervise clean rooms and support zones; ensure adherence to SOPs and maintain at least an L1 license.

• Direct packaging operations enforcing conduct standards and SOP compliance.

• Proactively generate and assess minor DRs & CAPAs with cell members.

• Implement and evaluate level 0 & level 1 modification controls.

• Conduct local area and system audits.

• Train and mentor Operations staff and QA colleagues.

• Communicate effectively attend Tier 1 meetings and contribute to planning and problem-solving activities.

• Support re-validation activities for assigned production cells.

• Observe incubate read and report on media fills.

• Perform cleanroom physical checks velocities air patterns DOP tests and particle counting.

• Re-qualify autoclave load patterns and test sterilizing filters.

• Validate cleaning processes and conduct AQL-based visual inspections.

Experience / Qualifications:

• Minimum 3 years of experience in sterile pharmaceutical manufacturing or related environments.

• Preferred science-based degree such as Microbiology Chemistry Biology or Pharmacy.

• Strong knowledge of cGMP and regulatory requirements for pharmaceutical production.

• Excellent interpersonal skills with the confidence to challenge behaviors at all levels.

• Proactive approach to continuous improvement problem-solving and project work.

Why Join Us:
Our package includes competitive pay pension healthcare and a dynamic collaborative environment. Join our Swindon team contribute to the manufacture of life-changing therapies and work in a facility recognized for its innovation quality and global impact.