Process Validation Specialist – MS&T

SOKOL GxP Services

. Support process validation activities, including aseptic process simulations and validations.

Posted 10/23/2026contractDevens • Massachusetts • United StatesJuniorMid-Level💰 $65,312 - $71,552 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in process validation activities, including aseptic process simulations and compliance with cGMP requirements. Proficient in technical writing for protocols, validation reports, and SOPs, with strong communication skills to collaborate effectively with cross-functional teams.

Highest-signal resume keywords

Process Validation ActivitiesCGMP ComplianceTechnical WritingAseptic TechniquesBiopharmaceutical Operations

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Process ValidationAseptic Process SimulationsTechnical Protocol PreparationValidation Report WritingSOP DevelopmentChange Control DocumentationCleanroom GowningProcess Lifecycle ManagementBiochemistry KnowledgeEngineering Knowledge

Soft Skills

Excellent Written CommunicationExcellent Verbal Communication

Industry Keywords

CGMP RequirementsBiopharmaceutical RegulationsCell Therapy RegulationsManufacturing Science and Technology

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.
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

Comp & perks

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.