Process Validation Engineer Ms T Validation

Process Validation Engineer (MS&T Validation)- Pharma (Hybrid Devens, MA)

We are seeking a Process Validation Engineer for our global pharmaceutical client. This person provides process validation support to the Devens Cell Therapy Facility (CTF) and participates in facility, process, and aseptic validation activities, including support of the Aseptic Process Simulation Program and implementation of process lifecycle management changes.

This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite at the client's office in Devens, MA.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

Responsibilities:

• Responsible for oversight of CTF Process Validation activities including, but not limited to Aseptic Process Simulations/ Validations (APS/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.

Requirements:

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

• Experience in Technical writing such as SOPs, protocols, summary reports and/or change controls is required.

• Manufacturing background with Manufacturing Science and Technology Validation experience is a must.

• Experience in cGMP's and multi-national biopharmaceutical/cell therapy regulations

• Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline, is required