Lead QA Technician

<p style="text-align:left"><b>Work Schedule</b></p>12 hr shift/nights<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>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.)<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p>Thermo Fisher Scientific Inc. offers an exciting opportunity to join a <b>top-tier Manufacturing team at our Swindon, UK site</b>, a leading facility specializing in <b>sterile pharmaceutical production</b>, including liquids and lyophilized products for clinical and commercial use. The Swindon site features <b>state-of-the-art filling lines, lyophilizers, and advanced packaging capabilities</b>, and is fully compliant with international regulatory standards such as <b>MHRA and FDA</b>. As part of our global network, the site plays a <b>critical role in delivering vaccines and life-saving therapies to patients worldwide</b>.</p><p>This is a <b>hands-on, high-impact role</b> for candidates with <b>at least 3 years of experience</b> in sterile manufacturing or a related pharmaceutical environment. You will ensure <b>high-quality production</b>, proactively <b>identify and resolve operational issues</b>, and help drive <b>continuous improvement</b> in a fast-paced, innovative setting.</p><p></p><p><b>Responsibilities:</b></p><ul><li><p>Provide quality assurance oversight for operational tasks within the assigned team.</p></li><li><p>Review sterilization cycles, FMS systems, and other key cleanroom controls.</p></li><li><p>Manage logbooks and support area control compliance.</p></li><li><p>Perform online batch record review and close batches with LIMS &amp; SAP transactions and C of A generation.</p></li><li><p>Review, update, and maintain Standard Operating Procedures and Controlled Documents.</p></li><li><p>Supervise clean rooms and support zones; ensure adherence to SOPs and maintain at least an L1 license.</p></li><li><p>Direct packaging operations, enforcing conduct standards and SOP compliance.</p></li><li><p>Proactively generate and assess minor DRs &amp; CAPAs with cell members.</p></li><li><p>Implement and evaluate level 0 &amp; level 1 modification controls.</p></li><li><p>Conduct local area and system audits.</p></li><li><p>Train and mentor Operations staff and QA colleagues.</p></li><li><p>Communicate effectively, attend Tier 1 meetings, and contribute to planning and problem-solving activities.</p></li><li><p>Support re-validation activities for assigned production cells.</p></li><li><p>Observe, incubate, read, and report on media fills.</p></li><li><p>Perform cleanroom physical checks – velocities, air patterns, DOP tests, and particle counting.</p></li><li><p>Re-qualify autoclave load patterns and test sterilizing filters.</p></li><li><p>Validate cleaning processes and conduct AQL-based visual inspections.</p></li></ul><p></p><p><b>Experience / Qualifications:</b></p><ul><li><p>Minimum <b>3 years of experience</b> in sterile pharmaceutical manufacturing or related environments.</p></li><li><p>Preferred science-based degree, such as Microbiology, Chemistry, Biology, or Pharmacy.</p></li><li><p>Strong knowledge of cGMP and regulatory requirements for pharmaceutical production.</p></li><li><p>Excellent interpersonal skills with the confidence to challenge behaviors at all levels.</p></li><li><p>Proactive approach to <b>continuous improvement, problem-solving, and project work</b>.</p></li></ul><p></p><p><b>Why Join Us:</b><br />Our package includes competitive pay, pension, healthcare, and a dynamic, collaborative environment. Join our <b>Swindon team</b>, contribute to the <b>manufacture of life-changing therapies</b>, and work in a facility recognized for its <b>innovation, quality, and global impact</b>.</p><p></p><p></p><p></p><p></p><p></p>