Are you an experienced Validation Specialist looking to make an impact in a growing organisation? This is a rare opportunity to join an established biotech organistaion at an exciting stage of expansion, where you will play a key role in shaping validation processes and supporting the introduction of new products.
Following a recent restructure, the company is seeking a hands-on validation professional to establish best practices and lead validation activities across R&D, QA, and Production. You will work closely with teams that genuinely collaborate, value open communication, and take pride in delivering high-quality outcomes.
Key Responsibilities
- Plan and execute validation projects in line with the Validation Master Plan.
- Develop and review validation protocols, reports, and supporting documentation.
- Perform risk assessments, gap analyses, and support change control and deviation processes.
- Coordinate technical transfers between QA, R&D, and Manufacturing.
- Ensure validation activities meet cGMP, regulatory, and internal SOP requirements.
- Act as a subject matter expert for validation during audits and inspections.
- Minimum 3 years hands-on validation experience within pharmaceutical, biotech, or medical device manufacturing.
- Strong understanding of validation principles, GMP, and regulatory frameworks.
- Skilled in process and equipment validation, risk assessment, and documentation.
- Confident communicator who can influence, question processes, and work collaboratively.
- Able to work independently and produce validation documentation from start to finish.
- Be part of a supportive and down-to-earth QA team that values initiative and teamwork.
- Opportunity to take ownership of validation strategy and drive process improvements.
- Work with a company introducing exciting new products and investing in growth.
