Job Description
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.
