Validation Technical Leader (Computerised Systems Validation) Location: Craigavon Hours: 37.5 Salary: Competitive Business Unit Sciences Open To : Internal & External Applicants Ref No.: HRJOB10245 The Role The primary purpose of this role is to perform, and supervise staff in, activities within the validation lifecycle of all GMP systems requiring validation. This role is specifically in relation to Computerised Systems Validation (CSV) in accordance with pharmaceutical industry regulations and guidance. Systems will range from standalone equipment to complex multi-site enterprise level systems. The post holder will be a positive role model, demonstrating excellence in technical and practical knowledge, customer care, planning, QA and results delivery. This role assumes an excellent understanding and demonstrated knowledge of CSV within the validation lifecycle. This allows the Technical Leader to not only perform their own activities but also provide advice to others from system selection through to delivery and ongoing compliance. The post-holder will be considered the CSV SME and will be required to attend and present at technical meetings and audits/inspections. Please see attached job description for further details Key Requirements Applicants must have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full time, permanent employment in the UK Essential Criteria · Degree (or equivalent) in Analytical Chemistry, Chemistry, Biochemistry, Engineering, IT or a related field OR significant relevant experience may be considered in lieu of Degree Level Qualification · Significant Experience in a CSV role within the Pharmaceutical Industry · Experience Reviewing and approving cGMP Validation Documentation · Understanding of Pharmaceutical Industry Regulations and Guidance related to CSV/DI Please see attached job description for further details of essential and desirable criteria. Apply Now Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible. Closing Date We will no longer be accepting applications after 5pm on Sunday 01 Dec 2024 RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CV’s received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.