Assistant process engineer # 26-26899

Duration: 06 Months Contract

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.

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.

Experience:

A minimum of 2 years’ experience in biopharmaceutical operations, or its equivalent is required.

Skillsets:

• Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations.
• Excellent verbal/written communication skills.

Education:

Bachelor’s degree in science, engineering, biochemistry or related discipline, is required.

About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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