Validation Engineer in Rahway, NJ at Johnson Service Group

Date Posted: 2/17/2021

Job Snapshot

Job Description

JobID: 382160

A validation and quality assurance provider are looking to hire a Validation Engineer for their Merck Rahway, NJ project site. This unique group works to develop and blueprint a universally implemented validation process that reliably achieves quality, affordable and available healthcare products.

This is a one-year assignment with the potential of being extended.

B.S. in Chemical Engineering, Mechanical Engineering, or related discipline and minimum of 3 years of experience working in GMP drug substance/product facilities.

Prior Merck and solid dosage experience a big plus.

Experience with:

  • Development of Standard Operating Procedures for pharmaceutical processing equipment.
  • Commissioning, qualification, and validation of GMP process equipment and associated documentation requirements.
  • Procurement of new equipment and associated milestones such as authoring URSs and attending SAT or FATs.

Preferred experience with:

  • Complex oral solid dosage or sterile pharmaceutical processing equipment and associated utility systems.
  • Data acquisition systems associated with pilot scale process equipment.
  • Facility start-up and new equipment introduction
  • Develop and approval of all relevant standard operating procedures required for the safe and compliant operations of the assigned system.
  • Responsible for the successful installation, commissioning/qualification, and operationalization of process equipment. Manage all elements of the work inclusive of but not limited to IQ, OQ, PQ, safety and GMP documentation requirements.
  • Participate during walkdowns and SATs to ensure proper installation and functionality of equipment. Verify accuracy of drafted SOP and update accordingly. Report status concerns and observations to Merck equipment leads.
  • Execute testing documentation associated with the relocation of previously qualified equipment.
  • Develop ‘Qualification Periodic Review Assessments’ for qualified equipment.
  • Coordination of the procurement of new equipment. Manage all elements of work inclusive of but not limited to coordinating meetings between vendors and Merck SMEs, authoring appropriate documentation, and attending acceptance testing.
  • Communicate status/metrics and escalate of issues associated with execution of activities.

JSG is a leading staffing agency specializing in a variety of industries. Having been named to three Staffing Industry Analysts (SIA) lists for the third year in a row, JSG continues to grow and offer hiring solutions to companies across the United States. JSG serves both busy recruiters and qualified candidates within multiple industries from our major offices headquartered in Chicago and Atlanta with local offices throughout the United States and Canada.

Please contact Allen Mudalel at 610 828-7356 and email resume to amudalel@jsginc.com

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