Randstad Validation Engineer in Swiftwater, Pennsylvania
salary:$69.92 - $91.70 per hour
date posted:Monday, January 28, 2019
industry:Miscellaneous Manufacturing Industries
Contract position: A Validation Specialist is needed for a global healthcare leader that discovers, develops and distributes therapeutic solutions focused on patient's needs in the Swiftwater, PA area. The Validation Specialist will be responsible for generating development / validation protocols and reports, compiling data packs and analyzing data for adherence to established acceptance criteria. No per diem available.
Responsibilities for the Validation Engineer
Typical processes being developed / validated include mixing, filling, formulation, visual inspection and lyophilization. Studies supporting these processes include hold time, CCIT, stability, Part 4 compliance.
Filling process validation. Aseptic Processing experience. Recent hands on experience executing process validations.
For filling, significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling equipment sufficient to identify process CPP's and generate detailed validation protocol requirements and coordinate execution
For formulation demonstrated experience with mixing, dispense and filtration process validation.
Requirements for the Validation Engineer
BS or MS in Engineering, Life Science or Physical Science required.
5+ years experience in Process Validation (formulation, filling, visual inspection and/or lyophilization), Performance Qualification, E&L, CCIT and Part 4 compliance.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.