Process Engineer
Durham, North Carolina
Job Id:
164611
Job Category:
Job Location:
Durham, North Carolina
Security Clearance:
No Clearance
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Madalyn Barry
Piper Companies is seeking a Process Engineer to support a large-scale laboratory expansion and modernization initiative for a global biotechnology and pharmaceutical organization. This Process Engineer will join a dedicated project team on a 12‑month contract, based onsite in Durham, North Carolina, and will play a hands-on role in transitioning laboratory space into a GMP‑light environment while supporting equipment installation, vendor coordination, and qualification activities.
Responsibilities of the Process Engineer include:
· Serve as the primary process engineering owner for laboratory buildout and equipment installation activities across multiple project phases.
· Coordinate with external vendors to obtain quotations, schedule onsite work, and support reinstallations, IQ/OQ activities, and documentation reviews.
· Partner cross-functionally with automation, utilities, validation, and project management teams to ensure smooth execution and issue resolution.
· Support GMP‑light readiness by reviewing qualification documentation in alignment with ALCOA principles and applicable compliance expectations.
· Maintain strong onsite presence in the lab, managing purchase orders, invoices, and day-to-day execution while anticipating and mitigating technical risks.
Qualifications for the Process Engineer include:
· 7–12 years of process engineering experience within regulated pharmaceutical or biotechnology laboratory environments.
· Solid working knowledge of GMP concepts, with the ability to apply compliance expectations in a GMP‑light setting.
· Familiarity with equipment installation and qualification processes, including IQ/OQ and vendor-led validation efforts.
· Experience supporting or working around laboratory equipment such as HPLC systems, biosafety cabinets, and downstream processing labs.
· Understanding of system capabilities, process intent, and how equipment is configured and utilized in an operational lab.
· Ability to work independently, manage multiple workstreams, and communicate effectively with internal stakeholders and external partners.
· Preferred experience with 21 CFR Part 11 concepts and data integrity considerations in laboratory systems.
· Prior exposure to automation systems, SAP onboarding, or utility-driven projects is a plus.
Compensation for the Process Engineer:
Salary Range: $165,000-$185,000/year (USD)
Benefits: Medical, Dental, Vision, sick leave if required by law, and 401(k) options
This job opens for applications on 4/14/26. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: process engineering, GMP, GMP light, laboratory expansion, equipment installation, IQ OQ, qualification, validation support, vendor management, CAPEX projects, pharmaceutical engineering, biotech manufacturing, laboratory operations, ALCOA, data integrity, 21 CFR Part 11, automation collaboration, utilities support, SAP, HPLC, biosafety cabinets, downstream processing, bioreactors, project engineering, technical operations, compliance, documentation review, cross-functional communication.
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