Assistant Process Engineer – Aseptic Validation

Sokolservices; Massachusetts; Hybrid; USD 43,000 - 47,000; Full time

Benefits offered by this job

Health insurance

Holiday pay

401(k)

Employee referral bonus

Job summary

Sokolservices seeks 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 management changes, and preparing protocols, reports, and summaries.

Hybrid work arrangement (50% onsite) with a daily schedule Monday–Friday, 40 hours/week. Bachelor’s degree in science/engineering/biochemistry and 2+ years in biopharma preferred; US work

Qualifications

• Bachelor's degree in science/engineering or biochemistry.
• Minimum 2 years of experience in biopharmaceutical operations.
• Excellent technical writing skills for SOPs, protocols, reports and change controls.
• Knowledge of cGMP requirements and related 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 requirements and maintain inspection readiness.
• Collaborate with MS&T teams to support validation activities.

Skills

Technical writing

Communication skills

Biopharmaceutical knowledge

Education

Bachelor's degree in Science/Engineering/Biochemistry

Job description

Sokolservices seeks 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 management changes, and preparing protocols, reports, and summaries.

Hybrid work arrangement (50% onsite) with a daily schedule Monday–Friday, 40 hours/week. Bachelor’s degree in science/engineering/biochemistry and 2+ years in biopharma preferred; US work