PROCESS ENGINEER (BATAM)

Core Objective:  Support Production Manager to ensure manufacturing processes run efficiently, consistently, and in compliance with all quality standards and regulatory requirements.

This is achieved by optimizing production processes and establishing, maintaining, and controlling all critical manufacturing documentation.

Key Areas of Responsibility:

I. Production Process Engineering & Support

Process Ownership: Handle Group of Enginers. Serve as the technical owner for assigned manufacturing processes on the production floor.

Troubleshooting: Lead root cause analysis (RCA) for process deviations, quality issues, equipment malfunctions, and non-conformances.

Implement effective corrective and preventive actions (CAPA).

Continuous Improvement (CI): Identify and drive projects to improve yield, reduce cycle time, enhance product quality, lower costs (scrap/rework), and improve Overall Equipment Effectiveness (OEE). Utilize Lean, Six Sigma, and Kaizen methodologies. Lean & Gemba champion

Training: Train production technicians and operators on revised or new processes, procedures, and equipment.

II. Documentation System Management & Control

Master Document Owner: Develop, write, review, and update critical controlled documents, including:

Standard Operating Procedures (SOPs)

Manufacturing Work Instructions (WIs) and Batch Production Records (BPRs)

Process Specifications and Parameters Risk Management Documents (e.g., pFMEA, Process Flow Diagrams)

Batch Record & Data Review: Review completed production batch records, logbooks, and critical process data for accuracy, completeness, and compliance.

Ensure all deviations are properly documented.

Document Management System (DMS): Be the subject matter expert for the electronic or paper-based DMS, ensuring proper version control, access, and archiving.

III. Data Analysis & Reporting

Performance Monitoring: Analyze production data (yield, scrap, downtime, quality metrics) to monitor process health and performance trends.

Reporting: Generate regular reports on process performance, project status, and documentation metrics for management review.

Decision Support: Use data-driven analysis to justify process improvements, capital expenditures, and documentation changes.

Typical Interactions / Key Stakeholders:

Production/Operations Teams: Daily support and collaboration.

Quality Assurance (QA) & Quality Control (QC): Close partnership for deviations, CAPA, validations, and audit support.

Regulatory Affairs: Ensuring documentation meets submission requirements.

Research & Development (R&D): For technology transfer and scale-up.

Supply Chain & Planning: Providing input on process capabilities and constraints.

Maintenance & Calibration: Ensuring equipment performance supports process requirements.

Qualifications & Essential Skills

Education: Bachelor’s degree in Chemical, Mechanical, Industrial, Manufacturing Engineering, or a related scientific field.
Min 3 years in a process engineering role within a regulated manufacturing environment. Prefrably Plastic Molding environment

Technical Skills: Strong understanding of engineering fundamentals, statistics, and process control. Proficiency with manufacturing software (MES, ERP, PLM) and Document Management Systems.

Documentation Skills: Exceptional technical writing skills. Meticulous attention to detail and a deep understanding of document control principles.

Soft Skills: Excellent problem-solving (root cause analysis), communication, project management, and cross-functional collaboration skills. Ability to explain complex processes clearly.

Certifications (Preferred): Six Sigma (Green/Black Belt), Lean Manufacturing, Project Management (PMP), or relevant regulatory training.

Key Performance Indicators (KPIs):

Reduction in process deviations/scrap/rework rates.

Increase in process yield or OEE.

Successful and on-time completion of process improvement and validation projects.

Document accuracy and on-time closure of change controls.

Positive audit observations (minimize findings related to processes or documentation).

Reduction in batch record review time/errors.

JOB LOCATION: BATAM, INDONESIA