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