Validation Engineer

Catalent Pharma Solutions; Swindon; On-site; GBP 30,000 - 50,000; Full time

Job summary

Catalent Pharma Solutions in Swindon seeks a Validation Engineer to ensure product and process compliance with industry standards. The role involves data analysis, process validations, and supporting quality reviews, making it essential for maintaining operational excellence. Join a global leader in drug development and contribute to life-saving treatments while advancing your career in a supportive environment.

Benefits

Competitive Salary

Annual performance bonus

Pension scheme matching up to 8%

BUPA private medical insurance

Generous holiday entitlement

Access to LinkedIn Learning

Employee assistance programme

Cycle to Work Scheme

Electric Vehicle car scheme

Free on-site parking

Qualifications

• Experience in Quality Assurance, preferably in pharmaceuticals.
• Strong numeracy and literacy skills.
• Confident user of Microsoft Excel & Minitab.

Responsibilities

• Conducting validation assessments and maintaining validated processes.
• Writing and reviewing validation strategies and reports.
• Leading deviation investigations and implementing corrective actions.

Skills

Quality Assurance

Data Analysis

Root Cause Analysis

Numeracy

Literacy

Microsoft Excel

Minitab

Education

Science-based degree

Tools

TrackWise

Job description

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 forZydis 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.

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.

The Candidate:

• 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).

Why You Should Join Catalent:

• 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 Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.