Validation Specialist

Validation Specialist Job Number: 24-03327 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Validation Specialist for our client in Summit, NJ. ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity! Position Overview: Works cross-functionally to execute validation activities and prepare validation deliverables for Enterprise Manufacturing Execution System used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works. Partners with site Business Owners, CI Owners, Quality, and the global client’s 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. Responsible for ensuring the validation of the Enterprise Manufacturing Execution System and applications are done following the relevant Client procedures, such as CSV SOP but no limited and applicable health authority regulations. Required Qualifications: 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 on-call support rotation Knowledge 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) principles Understanding the concept of Critical thinking for Computerized Systems Familiar 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 WebMethods With advanced technical document writing and time management skills, including ability to prioritize and manage expectations Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties Bachelor's degree in a life sciences, engineering or technology discipline required Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment or an equivalent combination of education, experience and training may substitute. If hired, you will enjoy the following ECLARO Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO If interested, you may contact: Sofia Dela Torre Sofia.DelaTorre@eclaro.com (332) 206-0779 LinkedIn | Sofia Dela Torre Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.