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:

• Pay: $ 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.

• 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, clean rooms, or QC Microbiology is preferred.