Engineering - Assistant Process Engineer
Global Staffing & Talent Solutions•Devens, MA
•Onsite
About The Position
ECLARO is seeking an Assistant Process Engineer for its client, a biopharmaceutical company, in Devens, Massachusetts. The posting describes the position as providing process validation support to the Devens Cell Therapy Facility (CTF). The Senior Specialist, MS&T Validation participates in facility, process, and aseptic validation activities, including support for the Aseptic Process Simulation Program and implementation of process lifecycle management changes. The role reports to the Associate Director of Manufacturing Science and Technology Validation.
Requirements
- Experience with cGMP and multinational biopharmaceutical/cell therapy regulations.
- Excellent verbal and written communication skills.
- Bachelor’s degree in science, engineering, biochemistry, or a related discipline.
- At least 2 years of experience in biopharmaceutical operations, or equivalent.
Responsibilities
- Oversee CTF process validation activities, including Aseptic Process Simulations/Validations (Client/APV) and other lifecycle management changes.
- Prepare written protocols, reports, and summaries supporting validation studies.
- Ensure safe and compliant cGMP operations and maintain permanent inspection readiness.
- Participate in facility, process, and aseptic validation activities.
- Support the Aseptic Process Simulation Program and implementation of process lifecycle management changes.
Benefits
- 401(k) Retirement Savings Plan administered by Merrill Lynch.
- Pretax commuter benefits through Commuter Check.
- Eligibility to purchase medical, dental, and vision insurance through ECLARO.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
