# Assistant Process Engineer - MS&T

**Company:** [SOKOL GxP Services](https://jobs.workable.com/companies/a1S7XpqSYfMsm6jbTL9fWC.md)
**Location:** Devens, United States
**Workplace:** hybrid
**Employment type:** Contract

[Apply for this job](https://jobs.workable.com/view/5fc80437-94bb-4240-b5c7-4c14b4f3455e)

## Description

We are seeking an Assistant Process Engineer 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.