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Senior Process Development Engineer (cGMP – Pharmaceutical) JD818756

JD818756

DPS is looking for an experienced Senior Process Development Engineer to work with a pharmaceutical client in the Boston, MA area. This individual would need to be able to step in with minimal training to execute based on the project goals and must be able to work independently with minimal supervision. The ideal candidate will be able to accomplish multiple tasks concurrently and think independently.

Category:
Science
Location:
Massachusetts
Years of Experience Req.:
4+
Date Posted:
15/02/2019
Days Remaining:
13
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior Process Development Engineer (cGMP – Pharmaceutical)         JD818756

Boston, MA area

 

Summary:

 

DPS is looking for an experienced Senior Process Development Engineer to work with a pharmaceutical client in the Boston, MA area. This individual would need to be able to step in with minimal training to execute based on the project goals and must be able to work independently with minimal supervision.  The ideal candidate will be able to accomplish multiple tasks concurrently and think independently.   

 

Responsibilities:

  • Author or support authoring of manufacturing batch records, change controls, deviation impact assessments, risk assessments, process control strategies, PPQ protocols and regulatory filings.
  • Perform and support data monitoring of manufacturing processes to understand process capability and troubleshoot investigation-driven events.
  • Develop/understand and manage the use of tools and templates that can be used to quantify impact and criticality for parameters and attributes within company and/or CMO unit operations.
  • Function as a process and technology subject matter expert; provide on-the-floor and on-site technical support for manufacturing runs.
  • Must demonstrate awareness of QbD/Control Strategy.
  • Must be detail-oriented (GLP, GDP, GMP a plus).
  • Design of experiment, knowledge of statistics, data entry and analysis.
  • Must demonstrate technical writing ability.

 

Qualifications:

  • Minimum 4+ years’ experience in Process Development within a GMP environment.
  • Advanced degree in a scientific discipline (Cell or Molecular Biology, Biochemistry, Chemical Engineering, Biochemical Engineering, or related field) with relevant experience in mammalian cell culture operations and process development.
  • Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment.
  • Experience in development and/or characteriz508965.480933ation of small molecule or viral vector manufacturing processes.
  • Experience with cGMP, ICH guidelines, PPQ (process validation), control strategy development, and working within a Quality organiz508965.480933ation.
  • Excellent problem solving skills.
  • Proficiency utiliz508965.480933ing statistical software such as R, JMP, Minitab, etc.
  • Able to creatively manage time and elevate relevant issues to project lead and line management.
  • Strong scientific and technical writing.
  • Detail oriented with excellent verbal and written communication skills.
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