Lead QA Technician

Work Schedule

12 hr shift/nights

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.