Engineering - Assistant Process Engineer

Global Staffing & Talent Solutions•Devens, MA

2d•Onsite

About The Position

ECLARO is looking for an Assistant Process Engineer for our client in Devens, MA. The client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines. The MSAT Process Engineering Contractor will support Manufacturing Science and Technology (MSAT) activities, with a focus on Out-of-Specification (OOS) investigations.

Requirements

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or related technical discipline.
Minimum 0–2 years of industry experience.
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.
Ability to work collaboratively in a fast-paced environment.
Strong analytical and critical-thinking skills with attention to detail.
Effective communicator, able to work cross-functionally with Quality, Manufacturing, and Engineering stakeholders.

Nice To Haves

Strong technical understanding of cell therapy manufacturing processes

Responsibilities

Support OOS investigations; may take on investigation ownership as appropriate.
Review batch records, process data, equipment logs, and analytical results to support investigation findings.
Partner with Quality Assurance, Quality Control, Manufacturing, and Engineering teams to gather data and align on investigation scope and conclusions.
Present investigation findings and technical rationale to cross-functional teams and management as required.