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MSAT Process Engineer (cGMP – Pharmaceutical) JD818681

JD818681

DPS is seeking a highly motivated individual with a BioPharma client in the Boston, MA area. As a Process 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. This role will focus on aspects of ensuring a robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products.

Category:
Engineer Chemical
Location:
Massachusetts
Years of Experience Req.:
5+
Date Posted:
15/07/2019
Days Remaining:
26
Employment Type:
Full-time
Education Level Req.:
Bachelors

MSAT Process Engineer (cGMP – Pharmaceutical)              JD818681

Boston, MA area

 

DPS is seeking a highly motivated individual with a BioPharma client in the Boston, MA area.  As a Process 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.  This role will focus on aspects of ensuring a robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products.

 

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, and reports).
  • 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 characteriz506552.643296ation, ranging from drafting procedures to execution of laboratory studies.
  • Support cross-functional technology transfer teams for cGMP.
  • Collaborate with another site or clients to ensure success of scale up/process transfer.
  • Execute cell culture or downstream laboratory work while maintaining good laboratory practice.


Education and Skills:

  • Bachelor or advanced degree in Biochemical, Chemical Engineering or a related scientific discipline such as Chemistry or Biology.
  • Looking for 3+ years’ relevant experience or Master’s degree with 1-2 years’ experience.
  • Must have cGMP pharmaceutical MSAT or technical services, technology transfer or process development experience.
  • Strong interpersonal and communications skills; written and oral.
  • Ability to function in a fast-paced dynamic team environment and balance prioritiz506552.643296e multiple projects
  • Laboratory experience preferred.
  • Knowledge of cell and gene therapy vector production is highly desirable.
  • Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus.
  • Knowledge of data management tools and statistical process controls is preferred.
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