Assistant Process Engineer - MS&T

SOKOL GxP Services; Harvard (MA); Hybrid; USD 43,000 - 47,000; Full time

Benefits offered by this job

Health insurance

Dental and vision options

401(k) program

Employee referral bonus

Job summary

SOKOL GxP Services is seeking an Assistant Process Engineer to support process validation activities at a cell therapy manufacturing facility in Devens, MA. The role focuses on aseptic process simulations and validations (APS/APV), lifecycle changes, and preparing validation protocols, reports, and summaries.

Required: Bachelor's degree in Science/Engineering/Biochemistry; at least 2 years in biopharmaceutical operations; strong technical writing; knowledge of cGMP; US work authorization.

Qualifications

• Bachelor's degree in Science, Engineering, Biochemistry, or related discipline.
• Excellent technical writing skills (proposals, SOPs, protocols, change controls).
• Knowledge of cGMP requirements and biopharmaceutical regulations.

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 and maintain inspection readiness.
• Collaborate with MS&T teams to support validation activities.

Education

Bachelor's degree in Science/Engineering/Biochemistry

Job 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.

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.

• 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.