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Summit, New Jersey Apex Systems
Apex Systems is seeking a Validation Technical Writer to work cross-functionally with Facilities, Engineering, Manufacturing, MST and Quality groups to lead Equipment Commissioning and Qualification (ECQ) deviation investigations to support qualification of equipment, utilities, facility and laboratory instruments used in CAR-T manufacturing. Responsibilities Responsible for working with the Manufacturing, MST, Facilities, Engineering teams to agree on appropriate CAPAs as needed. Write, revise, and review of all related GMP documentation for ECQ including qualification protocols for equipment, utilities, facility, lab instruments (IOQ, OQ, PQ), User Requirement Specifications (URS), Requirements Traceability Matrixes (RTM), Validation Summary Reports (VSR), etc. Lead ECQ deviation investigations to ensure on time closure Draftrevise IOQ, PQ protocols, RTMS, VSR, URS, etc. Participate in cross-functional deviation and CAPA meetings and initiatives Demonstrated ability to collaborate with Manufacturing Operations, QA, Facilities, MST, and other groups to appropriately assign deviation investigations and CAPAs, and support closure Serve as a credible SME as needed during audits to present and defend deviation investigations Identify opportunities to streamline the deviation investigation process for thorough, efficient investigations Other duties may be assigned, as necessary Qualifications Masters degree with 2 years of experience in Manufacturing Technical Writing OR Bachelors degree plus 3-4 years of experience in Manufacturing Technical Writing OR Associate Medical Technical degree and 8 years of Manufacturing or Operations experience Previous experience leading and closing equipment, utilities, facility, lab instruments deviation investigations. Understanding of equipment, utilities, facility, lab instruments qualification, and commissioning processes Background to include an understanding of biology, chemistry, medical or clinical practices Knowledge of cell culture, cryopreservation, and aseptic processing for cell therapy drug products is a plus Knowledge of cGMPFDA regulated industry Basic mathematical skills required Strong technical and compliance writing capability Proficient in MS Office applications For immediate consideration, please email your updated resume to Apex at with "Validation Technical Writer" in the subject line. EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or