BoehringerPRD
Validation Execution Specialist
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Validation Execution Specialist
Validation Execution Specialist – Pirbright Site
About the Role
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.
This is a fixed-term contract until December 2027.
Key Responsibilities
Core Validation Delivery
- Ensure the successful delivery of validation and qualification activities in accordance with the Site Validation Master Plan (SVMP).
- Coordinate and support validation activities for utilities and facilities, including:
- Revalidation of water systems
- Gases (HVAC, TCUs, Sterilising In-Place (SIP), steriliser systems, etc.)
- Maintain compliance with classified rooms/zones (A, B, C, D) concerning both physical and microbiological contamination control strategies.
Documentation & Study Management
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Generations, review, and/or approval of validation documentation, including but not limited to:
- Validation Master Plan
- Protocols, IQ, OQ, PQ, URS
- Impact & Risk Assessments
- Traceability Matrixes
- Periodic Reviews
- Certificates, Deviations & Investigations
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Support the validation of new products through documentation (validation plans, procedures).
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Provide monthly recurring validation reporting in SVMP for site management.
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System & Project Support
- Act as a Validation SME for systems (e.g., computerised systems, spreadsheets) and cross-functional teams.
- Develop and review validation protocols and processes for:
- Gowning qualification sites
- Disinfectant validation
- Behavioural change strategies
- Support external contractors and teams in validation compliance, ensuring consistency and adherence to corporate validation standards.
Regulatory & Cross-Functional Compliance
- Guide and influence teams on GxP compliance, ensuring alignment with cGMP requirements.
- Support various committees (Water Committee, Change Control, QMR) with validation expertise.
- Collaborate to resolve quality-related issues, investigations, and CAPA-related follow-ups.
Audit & Technical Work
- Actively support audit preparations, including validation, qualification, and contamination audits.
- Review documentation such as SATs, FATs, commissioning, and decommissioning logs to support process adherence.
Requirements
- Education: Bachelor’s degree in Sciences, Engineering, Microbiology, or a related field, or with a formal validation qualification.
- Experience: Significant experience in Quality Assurance/Manufacturing within the pharmaceutical industry.
- Validation Expertise: Strong knowledge and hands-on experience in validation processes, with a deep understanding of regulated pharmaceutical guidelines (e.g., VMD, FDA, Annex 1).
- Technical Proficiency:
- Excellent knowledge of MS Office Suite.
- Advanced technical writing skills, including experience with GxP regulatory documentation.
- Sector Awareness: In-depth knowledge of industry guidelines (ISPE, PDA) and standards (ISO, HTM).
- Industry Specialties (Preferred):
- Expertise in biologicals or sterile manufacturing.
- Experience with water, HVAC, and pharmaceutical gases.
- Collaborative Skills: Ability to proactively work across functions to deliver validation activities.
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Additional Requirement: A Disclosure and Barring Service (DBS) check will be required for the successful candidate. Any offer of employment will be subject to satisfactory DBS clearance.
Why Work Here?
Boehringer Ingelheim is recognised as a Top Employer in the UK, offering:
- Strong people practices and supportive work environment.
- Commitment to exceptional HR policies and career development.
Learn more about our work culture: https://www.boehringer-ingelheim.co.uk/careers/uk-careers/why-great-place-work
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