Senior Process Engineer

1 month ago


Philadelphia, United States DPS Group Global Full time

Arcadis (DPS) is seeking a highly motivated individual with a BioPharma client in the Upper Merion, PA area. As a Process/Project Engineer, you will provide process development and engineering support for technology transfers, process validations and GMP. Additionally, you will draft and review protocols, production procedures, and process development reports, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements. You will work with other teams manage equipment qualification and support process validation as well as draft documentation for regulatory filings.

Key Responsibilities:

  • Lead process related deviations and provide technical support to manufacturing
  • Investigate, identify root cause for critical deviations and determine CAPA for manufacturing
  • Write product impact assessments to support deviations
  • Write and review technical documentation (batch records, SOPs, protocols & reports)
  • Participate and report to a cross-functional development team to advance production activities
  • Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
  • Design and execute process development studies to develop a thorough understanding of operating and performance parameters
  • Perform hands-on activities that support process development and process characterization, ranging from drafting procedures to execution of laboratory studies
  • Other duties as assigned

Qualifications:

  • Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related discipline with at least 5 years of pharmaceutical manufacturing, technology transfer & process development experience.
  • Project Engineering and Process Engineering Experience required
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • Mastery of scientific and engineering principles

Skills:

  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills
  • Excellent interpersonal, verbal and written communication skills
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Well-developed computer skills


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