Work Schedule

Rotational shift nights/weekends

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, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Warehouse

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Thermo Fisher Scientific Inc. offers a groundbreaking chance to join a top-tier team in Swindon, UK. As a key part of our Manufacturing team, you will be involved in setting up and running our powerful facility. This hands-on role is essential for ensuring high-quality production, identifying and solving issues promptly to support efficient manufacturing operations.

RESPONSIBILITIES:

• Offer quality assurance supervision for operational tasks within the designated team.
• Review sterilization cycles, FMS systems, and other key controls of clean rooms.
• Manage logbooks and support area controls.
• Perform online review of batch records.
• Close batch records with associates LIMS & SAP transactions and C of A generation.
• Review and update Standard Operating Procedures and Controlled Documents.
• Direct clean rooms and support zones; ensure behavior and conformity to SOPs, including entering clean rooms physically and keeping up with at least an L1 license.
• Direct the packaging departments; uphold conduct standards and adherence to SOPs.
• Actively produce and promptly assess minor DRs & CAPA with cell members.
• Produce and promptly evaluate/implement level 0 & level 1 modification controls with cell members.
• Conduct local area and local system audits.
• Train and mentor Operations staff and QA peers.
• Communicate effectively, attend Tier 1 meetings, and participate in planning and problem-solving activities.
• Offer re-validation resources to the aligned cell effectively.
• Observe, incubate, read, and write reports for media fills.
• Conduct clean room physical checks – velocities, air patterns, DOP tests, and particle counting.
• Perform autoclave load pattern re-qualification.
• Test sterilizing filters.
• Validate cleaning processes.
• Conduct AQL-based Visual Inspection.

REQUIREMENTS:

• Preferred relevant science-based degree, such as Microbiology, Chemistry, Biology, or Pharmacy.
• Proven experience in the pharmaceutical industry, preferably in sterile product manufacture.
• In-depth knowledge and understanding of cGMP and other regulatory guidelines for pharmaceutical manufacturing.
• Excellent interpersonal skills with the ability to challenge behaviors at all levels of the organization.
• Proactive approach to continuous improvement and project work.

Our package includes a variety of adaptable benefits like Pension and Healthcare, along with competitive pay. Join our enthusiastic team working towards making a tangible difference in the world!