Validation Specialist

We are a national staffing firm and are currently seeking a Validation Specialist for a prominent client of ours. This position is located in Thousand Oaks, CA 91320. Details of the position are as follows: Job Details Pay: $54.60-56.49 based on experience. 3-month assignment, possibility for conversion/extension based on performance and business needs. Monday - Friday: 1st Shift(Onsite) Position will be mainly responsible for support qualification of Climet environmental monitoring instruments used in cGMP manufacturing suites. This role will author, execute, and close validation documentation; develop associated procedures; and coordinate activities with Quality, Manufacturing, Quality Control and other stakeholders. Key Responsibilities: Lead qualification activities for Climet environmental monitoring instruments and related components. Develop qualification plans, risk assessments, and project timelines. Author, review, and execute IQ, OQ and PQ protocols. Prepare qualification summary reports and final closeout documentation. Draft and revise SOPs, work instructions, forms, and other controlled documents. Coordinate instrument installation, vendor support, calibration, and maintenance activities as applicable. Document, investigate, and support closure of protocol discrepancies, and exceptions. Work cross-functionally with Quality Control, Quality Assurance, Manufacturing, and Information Technology. Ensure qualification records are complete, accurate, inspection-ready, and maintained in the site document management system. Track project milestones, communicate status, identify risks, and drive timely completion of deliverables. Qualifications Bachelor’s degree in engineering, Chemistry, Biology, Microbiology, Biotechnology, Pharmaceutical Sciences, or a related technical field preferred. Minimum of 3 years of relevant validation, equipment qualification, Quality Control, Engineering, Quality Assurance, or technical operations experience in a regulated manufacturing environment. Minimum of 2 years of direct experience writing and/or executing qualification protocols and preparing associated controlled documentation preferred. Experience qualifying equipment, instruments, or systems in a pharmaceutical, biotechnology, medical device, or similarly regulated environment. Hands-on experience authoring and executing IQ, OQ, and/or IOQ protocols. Strong technical writing skills, including protocols, reports, SOPs, and discrepancies. Working knowledge of cGMP, Good Documentation Practices, and applicable regulatory requirements, including 21 CFR. Familiarity with document management systems and electronic quality systems, experience with execution of IOQs through Kneat a plus. Experience with environmental monitoring systems, airborne particle counters, Climet instruments, cleanrooms, or QC Microbiology is preferred. #J-18808-Ljbffr Virtual Company