Your newpany
You will be joining a leading biopharmaceutical manufacturer focused on delivering high quality,pliant products to global markets. The site operates to high GMP standards and supports a portfolio ofmercial and development programmes, with a strong focus on continuous improvement, operational excellence, and technical innovation.
Your new role
You will lead process and cleaning validation activities, planning and executing validation studies in support of PPQ batches, technology transfer, andmercial process optimisation across the site. Responsibilities include authoring validation protocols and reports, overseeing execution, analysing data, and summarising findings in line with GMP and site procedures.
The position involves collaboration with QA, QC, Operations, and Process Engineering, ensuring all validation studies meet regulatory, quality, and corporate standards. You will also support audits, change controls, and new product introductions across the site.
What you'll need to succeed
1. A Science based degree (BSc or MSc).
2. Minimum 3 years’ experience in process and cleaning validation within the pharmaceutical industry, ideally in sterile manufacturing.
3. Strong working knowledge of GMP, EU/US regulatory guidelines, the Orange Guide, and risk based validation approaches.
4. Experience with PPQ, protocol authoring, data analysis, deviation management, and technical report writing.
5. Proficiency with statistical tools such as Minitab or Excel.
6. Excellentmunication, organisational and cross functional collaboration skills.
7. Ability to manage multiple priorities and meet tight deadlines in a regulated environment.
8. Must have full rights to work in the UK. No Sponsorship is not available
What you'll get in return
9. Opportunity to join an established pharmaceutical organisation playing a key role in validation strategy and execution.
10. Exposure toplex manufacturing processes, audit preparation, cross functional delivery, and large scale validation projects, further progressing your technical expertise and industry experience.