Title: MS&T Validation Specialist Company: Ipsen Biopharm Ltd : Ipsen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care. The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make a difference. We attract and develop bold, agile and entrepreneurial individuals who take full ownership of their decisions, leaders drawn by a purpose to make a direct impact through their work in people's lives, all of which is underpinned by our Ipsen Way of Being. In your role as MS&T Validation Specialist, you will be responsible for defining and executing the validation strategy to establish and maintain the validated status of facilities, utilities, equipment and processes, with particular focus on cleaning validation. Key responsibilities… Ensure the validated status of site facilities, utilities, equipment and processes is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance / standards. Define the validation testing strategy for requalification / revalidation activities. Execute requalification, revalidation and periodic review activities in accordance with the Validation Master Plan schedule. Drive an integrated approach to commissioning and qualification. Define and execute the validation strategy associated with site projects covering a range of a range of facilities, utilities, equipment and processes in accordance with project timelines and customer expectations. Subject matter expert for specific areas of validation as defined by the Validation Manager. Develop expertise in Problem Solving, Investigation, Technical Writing and statistical analysis within the team. (with support from senior members of the team) Support the Continuous Process verification (CPV) process working alongside with Process S&T Team. Use a risk based validation lifecycle utilising quality risk management principles and tools (e.g. FMEA, HAZOP) to ensure that risks are appropriately identified and documented. Present validation packages during regulatory / internal / customer audits. Participate in the response to regulatory audit observations (as required). What we're looking for… Knowledge in Equipment, Cleaning and Process validation, Isolator Technology, Process simulations/Media fills Knowledge and understanding in Sterile Manufacturing of medicinal Drug products Knowledge in Lyophilisation, Isolator Technology, Process simulations/Media fills, drug product formulation and sterilisation techniques (Moist heat, Dry heat etc) Understanding of biologics process development, stability studies, product hold times, filtration studies, scaleup studies, Extractable & Leachable etc. is desirable. Knowledge in Technology transfer, New product Introduction, Facility fit, Gap analysis, Equipment compatibility assessment, engineering studies etc. Organized, target orientate, customer focused and clear communicator. Work effectively as part of a cross functional team and maintain good relationships with internal and external stakeholders. Demonstrate a willingness to engage in self-directed learning and a desire to develop their level of experience and expertise. Why Ipsen & Why Wrexham… We are a business that is experiencing exponential growth and change, therefore presenting a wide range of opportunities and challenges Major £multi-million investment in a New Drug Product Facility to increase the scale and capability of our Wrexham site, ultimately enhancing the products we develop for our customers A fantastic culture and working environment with many long-serving employees Huge commitment to Diversity & Inclusion - almost 50% of our top 160 leaders are women A genuine focus on the environment and sustainability - our Wrexham site is powered by 100% renewable electricity Competitive salaries and enhanced benefits package which includes annual bonus, generous pension scheme, wellness allowance and so much more. Awarded 'Best Workplaces' and 'Best Workplaces for Wellbeing' status in the Large Organisations category, as well as 'Best Workplaces for Women' in 2023. The pride of working for a company that directly impacts and changes lives for the better To all agencies: please no phone calls or emails to any employee of Ipsen in relation to this opening. All resumes submitted by search firms/employment agencies to any employee at Ipsen via email or any form of communication/method will be deemed the sole property of Ipsen, unless such search firms/employment agencies were engaged by Ipsen for this position and a valid agreement with Ipsen is in place. In the event a candidate who was submitted outside of the Ipsen agency engagement process is hired, no fee or payment of any kind will be paid. IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.