A validation and quality assurance provider are looking to hire a Packaging & Assembly Equipment Qualification Specialist for their East Greenbush, NY project site. This unique group works to develop and blueprint a universally implemented validation process that reliably achieves quality, affordable and available healthcare products.

Hourly rate up to $70.00
This is a 6-month + assignment with the potential of being extended. 

We are currently seeking a Packaging & Assembly Equipment Qualification Specialist with hands-on experience in equipment qualification, validation documentation, and aseptic operations. This individual will play a critical role in supporting packaging line and auto-injector assembly operations in a GMP-regulated environment.
Key Responsibilities: Develop and execute Equipment Qualification (EQA), Installation Qualification (IQ), and Operational Qualification (OQ) protocols for packaging and serialization systems, including cartoners, case packers, palletizers, and auto-injector assembly equipment. Conduct Area Clearance Assessments (ACA) for packaging and assembly line equipment to ensure readiness and compliance. Author qualification documents, including OQ protocols, based on User Requirements Specifications (URS) and Equipment Qualification Assessments (EQA). Support the drafting and execution of traceability matrices and perform OPQ (Operational Performance Qualification) runs on filling lines. Review key Software Life Cycle (SLC) documentation such as HDS, SDS, Input/Output Lists, Alarm Lists, Set-point Lists, and Recipe Lists. Assist the engineering team in drafting recipes and set points for automated assembly machines. Review and verify calibration and maintenance plans in the BMRAM system. Conduct and support Data Integrity Assessments and FMEA Risk Assessments, ensuring high and moderate-risk items are properly addressed within qualification protocols. Demonstrate strong aseptic gowning skills, with training in gowning modules and cleanroom behavior.  
Johnson Service Group has been named to the list of Largest Staffing Suppliers in the United States by the Staffing Industry Analysts SIA.

Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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