Process Engineer

People work LLC is hiring for our client, a rapidly growing drug testing organization operating in stealth mode, developing next-generation laboratory testing solutions. We are seeking a Process Engineer I to support immediate manufacturing, and validation needs while helping build scalable, compliant processes for long-term growth.

This role is ideal for an engineer who enjoys hands‑on problem solving, working in regulated environments, and driving continuous improvement from benchtop through full automation.

• Design and develop process and manufacturing fixturing
• Write and maintain manufacturing documentation
• Execute IQ/OQ/PQ performance qualification and testing
• Collaborate cross‑functionally with R&D, Quality, and Manufacturing teams

• Lead NCR, CAPA, and deviation investigations across all assembly lines
• Serve as acting supervisor for Electro Mechanical Assembly Manufacturing, as needed
• Own and maintain document management systems and workflows
• Drive continuous improvement initiatives, including transitions from benchtop to semi‑automated and fully automated processes
• Manage change control activities to ensure compliant and controlled process evolution

• BS, or MS in Mechanical Engineering or a related discipline
• 3+ years of relevant experience in process and/or product development
• 2 years of experience working in a regulated environment (Medical Device, Pharmaceutical, Diagnostics, or similar)

• Proficient in MS Office and CAD software;
  Solid Works preferred
• Working knowledge of machining techniques, 3D printing, and other material manufacturing processes
• Shop experience (lathes, mills, etc.) and rapid prototyping using 3D printers is a plus
• Familiarity with validation, quality systems, and regulated manufacturing practices
• Experience in Tech/Process Transfer, Design of Experiments (DOE) and Lean Manufacturing
• Understanding of Quality Management Systems, Design Controls, Product and Process Validation

• Join a confidential, high‑impact drug testing organization
• Play a key role in building manufacturing and validation processes from the ground up
• Work in a collaborative, fast‑paced, and technically challenging environment
• Competitive compensation and benefits

🔒 Due to the confidential nature of our work, additional details will be shared during the interview process.

Apply here or contact us directly to learn more.