Commissioning and Qualification Specialist

About the Company: Gabe, Inc. ® is searching for a Commissioning and Qualification Specialist with experience in C&Q activities for equipment and analytical instruments.About the Role: A Commissioning and Qualification Specialist will be responsible for collaborating with clients to develop C&Q strategies and executing various protocols in compliance with local, corporate & regulatory regulations.Responsibilities:Develop / Approve / Execute IQ, OQ & PQ protocols per approved timeframes.Develop/Approve documentation including, but not limited to: SOPs, Risk Assessments, Validation Plans, RV/IQ/OQ/PQ Protocols, Requirements Traceability Matrices, and Summary Reports.Responsible for execution, exception reporting, assisting in exception analysis and resolution in a GMP compliant manner.Manage cross functional team meetings which will interpret the client's needs and drive decision to meet expectations.Qualifications:BS/BA in Engineering, Computer Science, Biological or other related discipline or equivalent work experience.Required Skills:2-5 years of experience with performing C&Q activities.Technical understanding of production and/or laboratory operations.Previous experience working in an FDA regulated and/or GMP environment.Strong analytical skills with ability to translate sometimes ambiguous data sets into actionable insights and recommendations.Excellent (written and verbal) communication and interpersonal skills, solid organizational skills, and ability to contribute to a collaborative, flexible work environment.Expert knowledge of cGMP documentation practices required.Working knowledge in utilizing appropriate root-cause analysis tools & techniques.Basic computer skills including experience in the use of Microsoft word, Excel, etc.Pay range and compensation package:Gabe, Inc.® offers a competitive compensation and benefits package.Position is located at the Amgen Campus in Thousand Oaks, CA.Normal working hours are 8:00 a.m. to 5:00 p.m. Monday through Friday, however irregular working hours should be expected during project execution.Pay is hourly with overtime and is commensurate with qualifications and experience.

Created: 2025-06-17