Validation Execution Specialist

To support validation activities at the Pirbright Site, the Validation Execution Specialist will generate and/or revise validation documentation for utilities, facilities, processes, and equipment, ensuring delivery of commitments in line with timelines and internal/external validation regulations.

Tasks & responsibilities

• Responsible for the successful delivery of the validation and qualification activities according to the Site Validation Master Plan (SVMP) for the Pirbright Site.
• Coordinate and support Validation activities for utilities and facilities revalidation (Water systems, Gases, HVAC, TCUs, SIP, Sterilisers etc).
• Ensure HVAC validation activities are coordinated efficiently to maintain classified rooms/zones (A,B,C,D) in compliance and according to contamination control strategy of the site (from both physical and microbiological point of view).
• Manage external parties supporting validation activities.
• Review validation data packs, generate certificates, raise deviations and support investigation, as required.
• Responsible for providing support for the successful delivery of the Validation activities for systems, processes and procedures.
• Support Process validation activities for new products by writing, reviewing or approving validation documents.
• Support Computerised systems and Spread sheets validation.
• Support cross functional teams to establish protocols for miscellaneous validation activities such as Gowning qualification and disinfectant validation.
• Generation, review and/or approval of Validation documentation (Validation Plan, Protocols, Reports, Impact assessment, Risk assessment, URS, IQ, OQ, PQ, RA, Traceability Matrix, Periodic Reviews, etc) for the validation/qualification, when applicable.
• Ensure validation related activities are captured into change controls and new projects.
• Support change / project owners to identify validation needs.
• Act as a validation SME for new projects and change controls as appropriate.
• Support and provide guidance to validation contractors, End users, Engineers in the delivery of validation documentation ensuring that a consistent and best practice approach is adopted with regards to generation of validation documentation.
• Review documentation such as SAT, FAT, Commissioning, Decommissioning Documents.
• Interpret and apply regulation/policies/corporate and local procedures during cross-functional meetings building a culture of quality and validation compliance ensuring the fulfilment of the cGMP requirements.
• Guide and influence teams on GxP compliance.
• Support colleagues to resolve issues, Risk assessment, Periodic Reviews, Investigations, etc to support CAPA, Change Controls, Deviations and other Quality systems.
• Guide colleagues/ QMS records owners to delivering compliant, regulatory acceptable records and documentation within the regulated areas.
• Act as the Validation member / validation SME of different forums such as Water committee, change control committee, QMR etc.
• Actively support audit preparations and act as SME for validation, qualification, contamination control, classified room validation audit topics as needed.

Requirements

• Bachelor’s degree in Sciences, Engineering, Microbiology, or related field, or formal validation qualification.
• Significant experience in Quality Assurance/Manufacturing in a pharmaceutical company.
• Good knowledge & experience in Validation.
• Excellent knowledge of MS Office Suite.
• Excellent written and verbal communication skills; experience authoring technical documentation.
• In‑depth knowledge of the regulated pharmaceutical industry and compliance expectations (VMD, FDA, Eudralex Annex 1).
• Good understanding of industry guidelines (ISPE, PDA, ISO, HTM).
• Good understanding of GxP water systems, HVAC systems, pharmaceutical gases, etc.
• Experience in Biologicals beneficial.
• Experience in Sterile Manufacturing beneficial.
• Ability to work collaboratively across functions.

A Disclosure and Barring Service (DBS) check will be required for the successful candidate. Any offer of employment will be subject to satisfactory DBS certificate.

WHY THIS IS A GREAT PLACE TO WORK

Boehringer Ingelheim has been recognised as a Top Employer in the UK, demonstrating our commitment to building an exceptional workplace through strong people practices and supportive HR policies.