Job Description
Job DescriptionJob Title: Assistant Process Engineer
ID: 26-05321
Location: Devens, MA 01434 (50% onsite required)
Work Schedule: Mon-Fri (normal business hours)
Must haves:
- Bachelor's degree required
- Experience in Technical writing such as SOPs, protocols, summary reports and/or change controls.
- Manufacturing background with Manufacturing Science and Technology Validation experience
Summary
- 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.
Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com