Process Validation Specialist - MS&T
About The Position
The Process Validation Specialist will support process validation activities at a cell therapy manufacturing facility in Devens, Massachusetts. The role focuses on aseptic process simulations and validations (APS/APV), process lifecycle management changes, and preparing technical documentation such as validation protocols, reports, and study summaries. The position collaborates with Manufacturing Science and Technology (MS&T) teams to support validation activities and maintain compliance with cGMP requirements and inspection readiness. This is a hybrid W-2 contract position, with 50% onsite work in Devens, Massachusetts. The contract is six months, with a possible extension up to two years. The schedule is Monday through Friday during normal business hours, with a maximum of 40 hours per week. The hourly rate is $31.40–$34.40. C2C arrangements and visa sponsorship are not available. The client retains the right to hire the contractor directly.
Requirements
- Bachelor's degree in Science, Engineering, Biochemistry, or a related discipline.
- Minimum of 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.
Nice To Haves
- 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.
Responsibilities
- Support process validation activities, including aseptic process simulations and validations (APS/APV).
- 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.
Benefits
- Health insurance with dental and vision insurance options.
- Holiday pay.
- 401(k) program.
- Employee referral bonus program.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
