Validation Engineer II

Location: Princeton, NJ
Department: Azzur Princeton, LLC

Job Description

Essential Duties and Responsibilities:

  • Successfully validate, qualify, or requalify laboratory and / or manufacturing equipment in a regulated GxP environment
  • Perform (hands on) field execution of commissioning and/or validation documentation
  • Understand deliverables of project requirements originating from the proposal, specifications, meetings, verbal direction, or other means
  • Write/Review engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV)
  • Ensures identification and communication of project risks, development of risk plan and assists core team in the proactive management of risk response strategies

Qualifications:

  • BS in Engineering, Science or equivalent technical degree
  • At least 5 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry
  • Excellent written and verbal communication skills; excellent technical writing skills
  • String interpersonal skills and the ability to work in a team environment
  • Strong working knowledge of FDA and cGMP regulations and documentation practices

 



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