Assistant Process Engineer

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.