Process Validation Specialist - MS&T

We are seeking an MS&T Process Validation Specialist to support process validation activities at a cell therapy manufacturing facility in Devens, MA.

This role focuses on supporting aseptic process simulations and validations (APS/APV), process lifecycle management changes, and the preparation of technical documentation, including validation protocols, reports, and summaries.

Key responsibilities:

• Support process validation activities, including aseptic process simulations and validations; Prepare technical protocols, validation reports, and study summaries; Support implementation of process lifecycle management changes; Ensure compliance with cGMP requirements and maintain inspection readiness; Collaborate with Manufacturing Science and Technology (MS&T) teams to support validation activities.
• Position details: Hourly rate: $31.40–$34.40; Contract length: 6 months with possible extension up to 2 years; Location: Devens, MA 01434; Work arrangement: Hybrid, 50% onsite; Schedule: Monday–Friday, normal business hours; Maximum hours: 40 hours per week; W-2 contract position; No C2C options; No visa sponsorship.

Requirements

• Required: Bachelor's degree in Science, Engineering, Biochemistry, or a related discipline; Minimum 2 years of experience in biopharmaceutical operations or equivalent; Excellent technical writing skills, including experience preparing SOPs, protocols, summary reports, and/or change controls; Knowledge of cGMP requirements and applicable biopharmaceutical or cell therapy regulations; Excellent written and verbal communication skills; Authorization to work in the United States without visa sponsorship.
• Preferred: Experience with aseptic techniques and processes; Experience with cleanroom gowning; Experience supporting process validation activities, including aseptic process simulations (APS/APV); Experience supporting process lifecycle management changes.