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.