Assistant Process Engineer

Integrated Resources, Inc

  • Devens, MA
  • 3 days ago
  • $34.42 Per Hour

Highlights

Education/Experience/ Licenses/Certifications: Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline, is required. Job Responsibilities: Responsible for oversight of CTF Process Validation activities including, but not limited to Aseptic Process Simulations/ Validations (Client/APV), and other Lifecycle Management changes.

Numbers & Facts

LocationDevens, MA

Description

Job Title: Assistant Process Engineer
Location: Devens, MA 01434
Contract Duration: 6 Months
  • Description: 50% Onsite Required
  • Work Schedule: Mon - Fri (Normal Business Hours)
  • Pay Rate: $34.42 Hourly
Job Description:
  • The Senior Specialist, MS&T Validation provides process validation support to the Devens Cell Therapy Facility (CTF).
  • The Senior Specialist participates in facility, process, and aseptic validation activities, including support of the Aseptic Process Simulation Program and implementation of process lifecycle management changes.
Job Responsibilities:
  • Responsible for oversight of CTF Process Validation activities including, but not limited to Aseptic Process Simulations/ Validations (Client/APV), and other Lifecycle Management changes.
  • Prepares written protocols/reports/summaries supporting validation studies.
  • Ensures safe and compliant cGMP operations, maintains permanent inspection readiness.
  • This position reports to the Associate Director of Manufacturing Science and Technology Validation.
Specific Knowledge, Skills, Abilities:
  • Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
  • Excellent verbal/written communication skills
Education/Experience/ Licenses/Certifications:
  • Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline, is required.
  • A minimum of 2 years’ experience in biopharmaceutical operations, or its equivalent is required.

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