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.

Benefits

• Health insurance with dental and vision insurance options.
• Holiday pay.
• 401(k) program.
• Employee referral bonus program.
• The client retains the right to hire the contractor directly.