Randstad Validation Engineer in Swiftwater, Pennsylvania

Validation Engineer

job details:

  • location:Swiftwater, PA

  • salary:$69.92 - $91.70 per hour

  • date posted:Monday, January 28, 2019

  • experience:4 years

  • job type:Contract

  • industry:Miscellaneous Manufacturing Industries

  • reference:146339

job description

Validation Engineer

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.

Benefits

  • 401K

  • Healthcare

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.