IR
Assistant Process Engineer
Integrated Resources, Inc
- 🇺🇸 United States
- On-site
- Manager or above
- 1 day ago
1 day ago
Location: Devens, MA 01434
Contract Duration: 6 Months
- Description: 50% Onsite Required
- Work Schedule: Mon - Fri (Normal Business Hours)
- Pay Rate: $34.42 Hourly
- 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.
- 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.
- Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
- Excellent verbal/written communication skills
- 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.
Assistant Process Engineer · Integrated Resources, Inc