Process Engineer
Biologics
Location: Wilson, NC
Travel: Limited domestic/international travel as required
Role Overview:
We are seeking an experienced Process Engineer to support a large-scale Large Molecule Drug Substance (LMDS) manufacturing project in Wilson, NC. This role drives the engineering design, start-up, commissioning, qualification (C&Q), and operational readiness for a GMP biologics facility. You will partner cross-functionally with Technical Operations, Quality, Validation, Automation, and external A&E/construction partners to deliver safe, compliant, and efficient manufacturing solutions.
Key Responsibilities:
C&Q Execution: Lead process systems through installation, start-up, commissioning, and qualification. System Ownership: Serve as the Subject Matter Expert (SME) for GMP large molecule manufacturing equipment. CAPEX Support: Drive strategic capital projects from design through execution and operational handover. Tech Transfer: Provide technical leadership for technology transfers and process-fit-to-plant activities. Troubleshooting: Provide hands-on troubleshooting and design modifications to support evolving plant needs. Compliance: Ensure all activities strictly align with GMP, safety, regulatory, and quality standards.
Required Qualifications
Education:
Bachelor s degree in Chemical, Mechanical, or Biochemical Engineering (or related discipline).
Experience:
8+ years of process/plant engineering experience in GMP large molecule biologics facilities. Facility Start-ups: Proven experience supporting greenfield or brownfield GMP facility start-ups (process systems, utilities, automation). Project Management: Track record of managing complex CAPEX projects and process improvements simultaneously.
Work Authorization:
Must be legally authorized to work in the US (open to US-based travelers and relocation). Presence: Ability to work onsite full-time in Wilson, NC.
Preferred Qualifications:
Specialized expertise in drug substance tech transfers or process-fit-to-plant activities. Advanced degree (MS, MBA, PhD), PE license, or FPX certification. Experience with Six Sigma, Lean methodologies, and managing A&E/construction partners.