Validation Engineer

We are currently seeking a Validation Engineer to join our Swindon team. This role is crucial in ensuring our products, equipment, computer systems, and cleaning processes remain qualified and compliant with industry standards. The Role:

• Conducting data analysis and reviewing commercial products to maintain validated processes through Continuous Process Verification (CPV), supporting Quality Annual Product Reviews (APRs).
• Writing Process Validation strategies, protocols, reports, validation plans, SIAs, DIAs, and executing computer system validation activities.
• Performing Cleaning Validation assessments and compiling relevant protocols and summary reports.
• Supporting equipment validation, including routine temperature mappings across fridges, freezers, freeze tunnels, stability facilities, incubators, and warehouse storage.
• Reviewing User Requirement Specifications (URS) and overseeing validation plans, Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and Equipment Qualification (IOPQ).
• Conducting validation history reviews, ensuring alignment with the latest regulatory requirements and identifying re-qualification needs.
• Leading deviation investigations using Root Cause Analysis and implementing appropriate Corrective and Preventive Actions (CAPA).
• Upholding employer and employee Environmental Health & Safety (EH&S) obligations, including participation in office safety inspections.
  
  Experience in Quality Assurance, preferably within the pharmaceutical or medical devices industry.
• A science-based degree or relevant industrial experience.
• Strong numeracy and literacy skills.
• Confident user of Microsoft Excel & Minitab.
• Experience with TrackWise or similar quality systems (preferred).
  
  Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) committed to helping people live better, healthier lives. We partner with pharmaceutical, biotech, and consumer health companies to support product development, launch, and full life-cycle supply. With over 40 global sites and thousands of scientists and technicians, Catalent delivers billions of doses of life-enhancing and life-saving treatments annually.
Our Swindon facility is the global center for Zydis® Technology-a best-in-class, orally dissolving tablet (ODT) platform. Zydis® formulations disperse almost instantly in the mouth without water, with over 20 products launched in 60 countries.


• Competitive Salary - Reflecting your experience and skills.
• Bonus & Benefits - Includes an annual performance bonus, a pension scheme matching up to 8% and life assurance. Enjoy BUPA private medical insurance, a generous holiday entitlement that increases with tenure, and the option to purchase additional leave. Plus, gain access to Reward Gateway, offering discounts at many national retailers.
• Career Development - Access high-quality training, mentoring, and cross-functional opportunities within Catalent's global network. Benefit from a subscription to LinkedIn Learning, providing access to 10,000+ online courses.
• Health & Wellbeing - Includes an employee assistance programme, on-site canteen facilities, and an active safety and "Patient First" culture. Take advantage of a Cycle to Work Scheme and an Electric Vehicle car scheme. Join Employee Resource Groups that foster a diverse and inclusive workplace. Plus, participate in charitable activities.
• Excellent Location - Just a two-minute drive from J16 of the M4, with free on-site parking.
We have been made aware of potential inaccurate job advertisements on third-party websites. Please consider Catalent's Career Site as the trusted and accurate source of information for any jobs available with Catalent. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit to explore career opportunities. Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.