Process Validation Specialist - MS&T

SOKOL GxP Services; United States; Hybrid; USD 43,000 - 47,000; Full time

Benefits offered by this job

Health insurance (dental & vision)

Holiday pay

401(k) program

Employee referral bonus program

Direct-hire option for client

Job summary

SOKOL GxP Services is seeking an MS&T Process Validation Specialist to support aseptic process simulations and validations at a cell therapy facility in Devens, MA. The role covers protocol and report preparation, along with lifecycle management changes to ensure cGMP compliance.

The position offers a hybrid work arrangement (50% onsite) with a 6-month contract term and potential extension, W-2 employment, and US work authorization. Hours are standard M–F, with up to 40 hours per week.

Qualifications

• 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 SOPs, protocols, reports, and 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.

Responsibilities

• Support 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 MS&T teams to support validation activities.

Skills

Technical writing

Communication

cGMP knowledge

Team collaboration

Regulatory knowledge

Education

Bachelor's degree in Science/Engineering/Biochemistry

Tools

APS/APV

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.