Process Engineer 3 - Large Molecule Biologics
Fusion Life Sciences
Process Engineer 3 Large Molecule Biologics
Location: Wilson, NC | Duration: 24 Months + Extension | Client: J&J
Job Summary
Seeking an experienced Process Engineer 3 to support the Large Molecule Drug Substance (LMDS) project. The role will focus on GMP biologics manufacturing, process engineering, facility start-up, technology transfer, and CAPEX project execution .
Roles & Responsibilities
- Provide process engineering expertise for GMP large molecule manufacturing systems, equipment, and processes .
- Support greenfield/brownfield facility start-up , including process systems, utilities, automation, equipment, and operations.
- Serve as a Process Engineering SME and process systems owner for manufacturing projects.
- Lead and support technology transfer, process improvements, engineering design, and manufacturing readiness activities.
- Work closely with A&E firms, construction teams, equipment vendors, Manufacturing, Quality, and Engineering groups.
- Translate manufacturing and business requirements into practical engineering solutions.
- Provide technical leadership to cross-functional project teams and resolve engineering or operational issues.
- Ensure project execution aligns with GMP, regulatory requirements, engineering standards, and right-first-time principles .
Required Qualifications
- Bachelor's degree in Chemical or Mechanical Engineering .
- 3+ years of process/plant engineering experience ;
- Strong experience in GMP large molecule biologics manufacturing .
- Experience with greenfield or brownfield GMP facility start-up .
- Background in process systems, utilities, automation, facilities, and manufacturing operations .
- Strong technical, analytical, communication, and cross-functional leadership skills.
- Pharmaceutical/biologics manufacturing and CAPEX project experience strongly preferred.
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