Assistant Process Engineer – MSAT

SOKOL GxP Services

. Support Manufacturing Science and Technology activities, focusing on Out-of-Specification investigations in a GMP-regulated manufacturing environment .

Posted 10/6/2026contractDevens • Massachusetts • United StatesJuniorMid-Level💰 $74,048 - $78,208 per yearWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates strong expertise in GMP-regulated environments, focusing on Out-of-Specification investigations and technical writing. Capable of collaborating cross-functionally and presenting findings effectively to stakeholders.

Highest-signal resume keywords

GMP ExperienceTechnical Writing SkillsProblem-Solving SkillsCell Therapy Manufacturing ExperienceAnalytical Skills

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

Out-of-Specification InvestigationsBatch Record ReviewProcess Data AnalysisImpact AssessmentsTroubleshootingAttention to DetailCritical Thinking

Soft Skills

Effective CommunicationCollaborationPresentation Skills

Tools & Technologies

GMP DocumentationElectronic Data Systems

Industry Keywords

Pharmaceutical IndustryBiopharmaceutical IndustryCGMPChemical EngineeringBiochemical EngineeringChemistry

About the role

Key responsibilities & impact

Support Manufacturing Science and Technology activities, focusing on Out-of-Specification investigations in a GMP-regulated manufacturing environment
Review batch records, process data, equipment logs, and analytical results
Help develop technically sound investigation findings and conclusions
Assume investigation ownership as appropriate
Work cross-functionally with Quality Assurance, Quality Control, Manufacturing, and Engineering
Gather data and align on investigation scope
Present investigation findings and technical rationale to cross-functional teams and management

Requirements

What you’ll need

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline
0–2 years of industry experience
Strong GMP experience within an industry environment
cGMP or Cell Therapy manufacturing experience
Technical writing skills for authoring impact assessments and Out-of-Specification investigations
Strong problem-solving, troubleshooting, and presentation skills
Familiarity with GMP documentation and electronic data systems
Strong analytical and critical-thinking skills with attention to detail
Ability to work collaboratively in a fast-paced environment
Effective communication skills with the ability to work cross-functionally with Quality, Manufacturing, and Engineering stakeholders
Authorization to work in the United States without visa sponsorship
Pharmaceutical or biopharmaceutical industry background preferred
Strong technical understanding of cell therapy manufacturing processes preferred

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.