Process Engineer III

The primary job function of this position is to provide technical support to cross-functional teams with little or no supervision, applying project management, engineering, and product/process knowledge to complete projects from concept through closure.

• Lead process engineering activities (Process Validation, Cleaning Validation, Equipment Qualification IQ/OQ/PQ, root-cause investigations).
• Support/monitor Production to troubleshoot material, process, and equipment issues; analyze data using structured techniques, data acquisition, process capability analysis, SPC, and other statistics.
• Provide technical evaluations for Engineering Change Orders and Supplier Changes (updates to specs/drawings/procedures; operator training).
• Design/develop equipment and processes for manufacturing; design/build/qualify fixtures, machines, or equipment.
• Support integration of new products into manufacturing (materials, processing, manufacture, cost inputs).
• Assist in validation of new/revised processes and equipment to meet standards/specifications.
• Design and execute engineering studies to test project hypotheses.
• Apply scientific/technical knowledge for timely execution; may supervise engineers/technicians.

• Bachelor's in Engineering/Science (or closely related) desired; or equivalent experience; 5+ years significant engineering/operational experience (post-graduate degree desired).
• Demonstrated competency; strong technical knowledge and judgment on complex problems.
• Collaborative communication and interpersonal/negotiation skills.
• Technical background in medical devices, pharmaceutical, biologics, or similar industries.
• Demonstrated competency with financial systems and fiscal control.

• 5+ years Process Engineering in GMP operations;
  Cleaning Validation and Equipment Qualification (IQ/OQ/PQ).

• paid time off (vacation/holidays/sick), medical/dental/vision insurance, 401(k), and eligibility for short-term incentive programs.