Assistant Process Engineer - MSAT

SOKOL GxP Services•Devens, MA

5h•$36 - $38•Hybrid

About The Position

The Junior MSAT Process Engineer will support Manufacturing Science and Technology activities with a primary focus on Out-of-Specification (OOS) investigations within a GMP-regulated manufacturing environment. The role will support OOS investigations by reviewing batch records, process data, equipment logs, and analytical results and helping develop technically sound investigation findings and conclusions. Investigation ownership may be assigned as appropriate. The engineer will work cross-functionally with Quality Assurance, Quality Control, Manufacturing, and Engineering to gather data, align on investigation scope, and present investigation findings and technical rationale to cross-functional teams and management. Strong GMP experience is important for this position. Pharmaceutical or biopharmaceutical industry experience is preferred.

Requirements

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

Nice To Haves

Pharmaceutical or biopharmaceutical industry background
Strong technical understanding of cell therapy manufacturing processes

Responsibilities

Support Manufacturing Science and Technology activities with a primary focus on Out-of-Specification (OOS) investigations within a GMP-regulated manufacturing environment.
Support OOS investigations by reviewing batch records, process data, equipment logs, and analytical results.
Help develop technically sound investigation findings and conclusions.
Work cross-functionally with Quality Assurance, Quality Control, Manufacturing, and Engineering to gather data, align on investigation scope, and present investigation findings and technical rationale to cross-functional teams and management.