Peoplework LLC
Peoplework 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 II
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.
Immediate Needs
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
Long‑Term Needs
Lead NCR, CAPA, and deviation investigations across all assembly lines
Serve as acting supervisor for Diagnostic Consumables 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
Experience
BS, MS
in Mechanical Engineering or a related discipline
3+ years
of relevant experience in process and/or product development
3‑5 years
of experience working in a regulated environment (Medical Device, Pharmaceutical, Diagnostics, or similar)
Knowledge & Skills
Proficient in MS Office and CAD software; SolidWorks 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
Why Join Us
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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Management and Manufacturing
Industries Human Resources Services
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Process Engineer II
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.
Immediate Needs
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
Long‑Term Needs
Lead NCR, CAPA, and deviation investigations across all assembly lines
Serve as acting supervisor for Diagnostic Consumables 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
Experience
BS, MS
in Mechanical Engineering or a related discipline
3+ years
of relevant experience in process and/or product development
3‑5 years
of experience working in a regulated environment (Medical Device, Pharmaceutical, Diagnostics, or similar)
Knowledge & Skills
Proficient in MS Office and CAD software; SolidWorks 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
Why Join Us
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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Management and Manufacturing
Industries Human Resources Services
#J-18808-Ljbffr