# Process Validation Specialist - MS&T

> SOKOL GxP Services · Devens, United States (Hybrid) · Contract · Posted 2026-10-22

**Salary:** USD 65,312–71,552

**Workplace:** hybrid

## 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.

## Apply

[Apply at SOKOL GxP Services](https://apply.workable.com/sokol-gxp-serivces/j/C45C4D68D2/apply)

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