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Process Engineer

Company: Analysts
Location: New Brunswick
Posted on: January 12, 2021

Job Description:

My name is Bhawna and I'm a Technical Recruiter with ACS Group, a leading information technology services and workforce solutions company.We currently have an opportunity for a "Process Engineer" with one of our clients in the "New Brunswick, NJ" area.Job Title: Process EngineerJob Location: New Brunswick, NJDuration: 12+ Months W2 ContractsSummaryThe successful candidate will provide systems, documentation and technical support for manufacturing of biologic drug products at Contract Manufacturing Organizations (CMOs) in the US.This position will report into the Associate Director of Parenteral ExM MS&TKey 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. This includes 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 assessmentQualifications, Knowledge and Skills Required:Education:* 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 is required.* 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 is required.Experience / Knowledge Desired:* 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.* Demonstrated strong oral and written communication skills, along with demonstrated project management experience.* Ability to work within cross-functional technical teams, across multiple cultures.BHAWNA PANWAR

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

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