Process Engineer

• 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

• 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

Medical, Dental, Vision, sick leave if required by law, and 401(k) options