Aseptic Process Validation Specialist - Hybrid Contract

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

Benefits offered by this job

Health insurance with dental and visão

Holiday pay

401(k) program

Employee referral bonus program

Job summary

SOKOL GxP Services seeks an MS&T Process Validation Specialist to support aseptic process simulations and validations at a Devens, MA facility. You will prepare protocols, reports, and summaries, and assist with lifecycle management changes to ensure cGMP compliance.

This is a hybrid, 50% onsite contract role. Qualifications include a BS in Science/Engineering/Biochemistry, 2+ years in biopharma operations, excellent technical writing, and strong communication skills.

Qualifications

• Bachelor's degree in Science, Engineering, Biochemistry, or related discipline.
• Minimum 2 years of experience in biopharmaceutical operations or equivalent.
• Excellent technical writing skills including SOPs, protocols, summaries, and change controls.
• Knowledge of cGMP requirements and related regulations.
• Excellent written and verbal communication skills.
• Authorized to work in the United States without visa sponsorship.

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.

Skills

Technical writing

cGMP knowledge

Verbal communication

Education

Bachelor's degree in Science/Engineering/Biochemistry

Job description

SOKOL GxP Services seeks an MS&T Process Validation Specialist to support aseptic process simulations and validations at a Devens, MA facility. You will prepare protocols, reports, and summaries, and assist with lifecycle management changes to ensure cGMP compliance.

This is a hybrid, 50% onsite contract role. Qualifications include a BS in Science/Engineering/Biochemistry, 2+ years in biopharma operations, excellent technical writing, and strong communication skills.