Process Engineer

Core Responsibilities

• Own and maintain process parameters for all production lines within the assigned building.
• Define standard operating windows and control limits.
• Monitor and improve process capability (Cp, Cpk).
• Ensure process documentation (work instructions, parameter sheets) is current and accurate.
• Provide on-floor technical support during process deviations.
• Drive improvements in:
• OEE (Overall Equipment Effectiveness)
• First Acceptance (FA) / RFT (right first time)
• Scrap reduction
• Cycle time optimization
• Lead structured problem-solving using:
• DMAIC methodology
• 5-Why analysis
• Fishbone diagrams
• Implement Lean manufacturing initiatives.
• Reduce cost of non quality (CNQ).

Validation & Change Management (Regulated Environment)

• Support validation activities such as:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Ensure process changes follow formal change control procedures.
• Conduct risk assessments (FMEA) for new or modified processes.
• Support compliance with:
• International Organization for Standardization standards (ISO 9001 / ISO 13485 as applicable)
• Good Manufacturing Practices (GMP)
• U.S. Food and Drug Administration regulations (if applicable)

Equipment & Technology Support

• Collaborate with Maintenance on preventive maintenance strategies.
• Define critical process parameters (CPPs).
• Support installation and commissioning of new equipment.
• Lead process trials and line qualifications.
• Analyze downtime trends and implement corrective measures.

Data & Statistical Analysis

• Analyze SPC data and process variation.
• Perform capability studies.
• Develop dashboards for process performance monitoring.
• Utilize statistical tools to identify systemic risks.

Cross-Shift Process Governance

• In multi-shift operations: Ensure consistent process execution across all shifts.
• Audit parameter adherence.
• Standardize troubleshooting guides.
• Support off-shift escalation when major technical issues arise.

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related field).
• 2–4 years of process engineering experience in manufacturing.
• Strong knowledge of:
• Statistical process control (SPC)
• Lever / Six Sigma tools
• Root cause analysis
• Process validation methodologies

Preferred Qualifications

• Lean Six Sigma Green Belt or Black Belt.
• Experience in plastics, injection molding, extrusion, or automated packaging systems.
• Validation experience in pharmaceutical or medical-related industries.
• Project management experience.