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Process Engineer

Company: Joule
Location: New Brunswick
Posted on: January 14, 2021

Job Description:

Title: Process EngineerLocation: New Brunswick, NJ Schedule: Mon-Fri (1st shift) Duration: 12 month contract Start date: ASAPEstablished Pharma company is looking for experienced Process Engineer to join their rapidly growing team! Looking to hire immediately!! Responsibilities:* Provide first line systems and documentation support to manage QE and Change Controls at CMOs in Trackwise, Infinity and other Quality and document systems* Provide technical support to contract manufacturing organizations to enable technology transfers and commercial manufacturing. * Review and approval of site documents such as characterization Protocols, Validation Protocols, Process Risk assessments, etc.* Support of critical manufacturing or complaint investigations including, root cause analysis, CAPA generation, and impact assessmentRequirements:* A Bachelor's Degree in relevant engineering or science discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) or requisite equivalent experience.* Hands-on experience with quality systems, documentation systems and ability to process change controls, deviations and CAPAs. * Good knowledge of Sterile or Biologics manufacturing technology, and experience in working with CMOs with a minimum of 5 years of experience.* Experience of working with Trackwise and or Infinity System to provide documentation support for change control and investigation* Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.* Strong technical writing skills.Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: Joule, New Brunswick , Process Engineer, Other , New Brunswick, New Jersey

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