Process Engineer

About the role

The Process Engineer will lead systematic investigations to ensure plant processes and equipment meet and exceed established requirements. This role focuses on process optimization, capability studies, equipment and process validation, automation, and lean improvements within a regulated manufacturing environment.

Key responsibilities

• Lead problem‑solving efforts using RCA, FMEA, and Fishbone techniques for technical issues, customer complaints, and internal deviations.
• Investigate and address GMP, quality, safety, and environmental issues, implementing corrective actions to prevent recurrence.
• Write, update, and verify working instructions, standard work, and documentation for new or changed processes.
• Participate in Operational Excellence activities, applying lean tools such as Value Stream Mapping (VSM) and SMED.
• Monitor plant performance, evaluate metrics, and drive continuous‑improvement projects.
• Develop and execute capability studies and statistical process control (SPC) for existing processes.
• Ensure compliance with preventive maintenance, calibration programs, and OEE targets.
• Manage equipment and process capital projects from justification through design, implementation, and startup.
• Support production managers with corrective actions, process control verification, and compliance reporting.
• Maintain a clean, GMP‑compliant workplace and verify safety equipment usage.

Required profile

• Proven experience in process engineering within a regulated manufacturing environment.
• Strong knowledge of GMP, quality, safety, and environmental regulations.
• Ability to lead investigations and implement corrective actions.
• Familiarity with lean manufacturing tools (VSM, SMED) and continuous‑improvement methodologies.
• Project management experience, including capital‑project justification and execution.

Required skills

• Root Cause Analysis (RCA)
• Failure Mode and Effects Analysis (FMEA)
• Fishbone diagram analysis
• Statistical Process Control (SPC)
• Capability study design and execution
• Lean tools: Value Stream Mapping, SMED
• Project Management techniques
• Preventive Maintenance and Calibration systems
• Overall Equipment Effectiveness (OEE) monitoring
• Process automation and control
• Equipment and process validation