Pharmaceutical Validation Technician

4 weeks ago

Swindon, Swindon, United Kingdom Catalent Full time

About Catalent: Catalent is a global leader in drug development and delivery, dedicated to bringing life-saving and life-enhancing products to patients worldwide. Our commitment to quality and safety drives our operations, ensuring that we meet the highest standards in the pharmaceutical industry.

Position Overview: We are seeking a Validation Engineer to join our team at the Swindon facility. This role is integral to our Validation team, focusing on the Pharmaceutical Validation processes. The Validation Engineer will ensure that our products, equipment, computer systems, and cleaning processes are properly qualified and maintained in compliance with industry standards.

Key Responsibilities:

  • Conduct thorough data analysis and review of commercial products to guarantee the Continuation of Validated Processes through Continuous Process Verification (CPV), contributing to Quality Annual Product Reviews (APR's). This includes performing Cleaning Validation assessments, drafting Cleaning Validation protocols, and compiling Validation Summary Reports.
  • Develop basic strategy documents for Process Validation activities, including writing Protocols and subsequent Reports, Validation Plans, and executing computer system validation activities.
  • Engage in Equipment Validations, such as Routine Temperature Mappings for various storage and processing equipment, and participate in Validation History Reviews to ensure ongoing compliance.
  • Review User Requirement Specifications (URS) and prepare Validation Plans, Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Installation and Operational Qualification (IOPQ) documents, and execute Equipment Validation activities.
  • Ensure that validation practices align with the latest regulatory requirements.
  • Promote and maintain a culture of health, safety, and environmental responsibility within the workplace.

Candidate Profile:

  • Proven experience in a Quality environment, particularly within the pharmaceutical or medical device sectors.
  • A relevant Science-based Degree or equivalent industrial experience.
  • Strong numeracy and literacy skills.
  • Proficient in Microsoft Excel and Minitab.

Why Join Us? Catalent offers rewarding opportunities for career advancement within a dynamic and growing international company. We work closely with pharmaceutical, biopharma, and consumer health companies to facilitate the development of new medicines from initial research through to clinical trials and market launch. With over 70 billion doses produced annually, each product plays a crucial role in the lives of patients globally.

Commitment to Safety: Catalent prioritizes the health and safety of its employees, visitors, and the patients we serve. We have adapted our recruitment and onboarding processes to ensure safety during these times.

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

Accommodations: If you require reasonable accommodation during the application or hiring process due to a disability, please inform us, and we will ensure appropriate assistance is provided.

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