Site Name: Cambridge Binney Street Posted Date: Feb 3 2025 Job Posting Deadline: February 14, 2025 Job Title: Validation Engineer Location: Cambridge Binney Street Are you looking for an opportunity to manage projects, identify areas of improvement, and support safety working practices? If so, this is the job for you. As a Validation Engineer you will be responsible for directly implementing, executing and supporting the validation strategy at use at the GSK Binney Street site ensuring it is harmonized with local, regulatory, and GSK standards. To ensure that GxP systems meet intended uses and complies with applicable regulations, current industry practices, and internal procedures. The candidate will be responsible for supporting the asset lifecycle (concept to retirement) of existing and new equipment or systems in the manufacturing suite, utilities, and facilities. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Key Responsibilities Review and approve draft protocols, executed protocols, protocol deviations, and protocol summary reports. Oversee and support CAPA and change control tasks related to the manufacturing and supply chain areas Generate, participate, or review lifecycle documentation - such as user requirements, functional specifications, functional requirements, configuration specification, project plans, GxP criticality assessments, trace matrix requirements, and system use documentation (system admin, user admin procedures). Provide assessments for investigations, and change controls Responsible for triaging and developing the governance around compliance documents related to the commissioning and qualification organization Present out to leadership on team metrics Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree with 7+ years’ experience with validation in relation to Biologics manufacturing equipment and processes, as well as utilities, and facilities. Experience with Validation lifecycle documentation (URS, FS, CS, IQ, OQ, etc.) Experience with cross function teams to deliver projects on time. Experience with Quality Systems (Change Controls, Investigations, CAPAs) Experience with ISPE GAMP 5, Data Integrity, USP 1058 Experience with 21 CFR Parts 210, 211, 820 requirements, EudraLex Annex 15, ICH Q7A, Q9 requirements Preferred Qualifications: If you have the following characteristics, it would be a plus: Excellent written and verbal communication skills. Excellent technical writing skills Strong interpersonal skills and the ability to work in a team environment. Flexible and adaptable to changing priorities with strong organizational skills. #LI-GSK Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. 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