CSV Engineer
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Role & Company Overview
📋 Role Overview & Responsibilities
Title: Validation Engineer (MSEO)Location: Summit, NJ - HybridDuration: 06+ Months (Possible Ext)
Job Description:The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works. The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle. The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant Client procedures, such as CSV SOP but no limited and applicable health authority regulations.
REQUIRED COMPETENCIES:Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation. Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotationKnowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principlesUnderstanding the concept of Critical thinking for Computerized SystemsFamiliar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs)Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethodsWith advanced technical document writing and time management skills, including ability to prioritize and manage expectationsOperate effectively and with minimal supervision, within a team or independently, performing projects and related duties
Education and Experience:Bachelor's degree in a life sciences, engineering or technology discipline requiredMinimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment. An equivalent combination of education, experience and training may substitute.
If you are not interested in looking at new opportunities at this time I fully understand. I would in that case be appreciative of any referrals you could provide from your network of friends and colleagues in the industry. We do offer a referral bonus that I’d be happy to extend to you if they turn out to be a great fit for my client.
Thank you for your time and for your consideration. I look forward to hearing from you.
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