Job Description
A client of Insight Global is seeking a detail-oriented and technically skilled Validation Engineer to support the qualification and validation of equipment, utilities, and processes in a regulated pharmaceutical environment. This role involves developing and executing IQ/OQ/PQ protocols to ensure compliance with cGMP and FDA guidelines. The engineer will lead validation activities for various equipment such as Vaporized Hydrogen Peroxide (VHP) units, Karl Fischer (KF) titration setups, general fume hoods, and vacuum ovens. Responsibilities include collaborating with cross-functional teams, troubleshooting equipment issues, maintaining validation documentation in accordance with compliance standards and supporting audits and inspections. The ideal candidate will have 1-2 years of experience in a GMP-regulated environment and a strong understanding of regulatory requirements and risk-based validation approaches. Exact compensation may vary based on several factors, including skills, experience, and education but will vary from 28-38/hr. Benefit packages while on contract for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
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Required Skills & Experience
-Experience working within a GMP (Good Manufacturing Process) environment
- 1-2 years of hands on experience with Validation Protocols (reading acceptance criteria, completing proper documentation)
- 1-2 years of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) experience
- 1-2 years of experience following and/or creating Standard Operating Procedures (SOPs) in a lab environment
Nice to Have Skills & Experience
Pharmaceutical or Medical Device experience
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.