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Description
To drive the completion of validation activities across the CGT Catapult’s Manufacturing Innovation Centres (Equipment / Facilities / Utilities / Laboratory Systems). The role supports both centres in Stevenage and Braintree. Responsibilities include:
* Critical Systems / Utilities / Equipment
* Cleaning
* Laboratory Equipment
* Computerised Systems
* HVAC
The Validation Specialist will author, execute, and report validation activities within cGMP framework, ensuring compliance with CGT Catapult’s QMS. The role involves supporting multiple projects, liaising with teams and SMEs, and possibly traveling within the UK and internationally.
Key Responsibilities
* Maintain validation knowledge and supervise validation exercises
* Work with vendors, author validation protocols/reports, drive project completion, and ensure QbD principles are incorporated
* Ensure risk-based validation in line with EU GMP Annex 11, 15, and GAMP 5
* Attend design meetings and factory acceptance tests
* Develop stakeholder relationships and ensure training and change management adherence
Non-Technical
* Work within multidisciplinary teams, establish external links, pursue professional development, and comply with safety policies
Experience
* GMP validation experience, knowledge of computer systems validation, and biopharmaceutical validation background
* Experience with validation teams, regulatory authorities, and clients
Skills, Knowledge, and Expertise
* Motivated, pragmatic, with understanding of validation requirements
* Project ownership, customer service orientation, collaborative, flexible, resilient, and communicative
* Willing to travel
Education / Qualifications
* Degree in life sciences or engineering, with knowledge of equipment and utilities validation in regulated environments
CGT Catapult values diversity and inclusion, holding bronze accreditation from Inclusive Employers in 2024.
Seniority level
* Associate
Employment type
* Full-time
Job function
* Quality Assurance
This job is active and accepting applications.
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