Validation Execution Specialist

THE POSITION

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.

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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.

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*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.

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