Process Engineer

Senior/Principal Process Engineer – Process System Owner

Location: Wilson, NC (Onsite)

Our client is seeking a Senior/Principal Process Engineer – Process System Owner to support the launch of a new Large Molecule Drug Substance (LMDS) manufacturing facility in Wilson, NC.

This is an opportunity to play a key role in bringing a state-of-the-art biologics manufacturing site online. You'll own critical process systems from design through startup, commissioning, qualification, and operational readiness while partnering with engineering, manufacturing, quality, automation, and external vendors to ensure successful project execution.

If you enjoy solving complex engineering challenges, leading cross-functional initiatives, and seeing projects through from concept to production, this is a great opportunity to make a lasting impact.

• Serve as the Process System Owner for biologics manufacturing systems throughout the project lifecycle.
• Lead process equipment and systems through installation, startup, commissioning, qualification, and handoff to operations.
• Troubleshoot process and equipment issues while identifying and implementing engineering improvements.
• Partner with manufacturing, quality, automation, facilities, utilities, and project teams to ensure successful startup and reliable operation.
• Collaborate with engineering firms, equipment vendors, and construction partners throughout design and execution.
• Support technology transfer activities and ensure new processes integrate successfully into manufacturing.
• Develop and implement engineering solutions that improve reliability, efficiency, and compliance.
• Lead technical discussions, provide engineering expertise, and mentor project teams when needed.
• Ensure systems meet GMP requirements while supporting safe, compliant, and "right first time" manufacturing execution.
• Drive continuous improvement initiatives across manufacturing processes and engineering systems.

• Bachelor's degree in Engineering (Chemical, Mechanical, Biochemical, or related discipline).
• 8+ years of process or plant engineering experience within GMP biologics drug substance manufacturing
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• Experience supporting greenfield or brownfield biologics manufacturing facility startups
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• Strong knowledge of:
• Process equipment
• Utilities
• Manufacturing systems
• Automation integration
• GMP manufacturing environments
• Experience supporting commissioning, qualification, startup, and operational readiness.
• Ability to lead multiple projects while working across cross-functional teams.
• Strong troubleshooting, communication, and technical leadership skills.

• Master's degree, MBA, PhD, or Professional Engineer (PE) license.
• Experience with technology transfer projects.
• Lean, Six Sigma, or FPX certification.
• Experience leading complex capital (CAPEX) manufacturing projects.

• Be part of a major biologics manufacturing expansion.
• Help bring a new manufacturing facility from startup to production.
• Own critical manufacturing systems from design through operational readiness.
• Collaborate with cross-functional teams including engineering, manufacturing, quality, automation, and external partners.
• Work on projects that directly support the production of life-changing biologic therapies.

This is an excellent opportunity for an experienced process engineer looking to take ownership of large-scale biologics manufacturing systems while working on high-impact capital projects in a GMP environment.

Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.

We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in…