Production Engineer, Fractionation

Position Purpose: 

The Production Engineer provides frontline engineering support to pharmaceutical manufacturing operations, ensuring equipment reliability, compliance, and performance throughout the asset lifecycle. The role supports troubleshooting, continuous improvement, and asset management activities in alignment with ISO 55000 Asset Management principles and GMP requirements, working closely with Production, Maintenance, Quality, and Engineering teams.

Main Responsibilities and Accountabilities:

1. Equipment Reliability & Operational Support

• Provide frontline engineering support for manufacturing equipment, responding to equipment-related issues on the production floor to minimize downtime while maintaining GMP compliance.

• Support troubleshooting of equipment breakdowns using structured problem-solving and reliability engineering methodologies.

• Participate in Root Cause Analysis (RCA) investigations and support implementation of corrective and preventive actions (CAPAs)

2. Maintenance & Asset Health Monitoring

• Analyze asset health data by reviewing corrective maintenance (CM) and preventive maintenance (PM) trends within SAP CMMS.

• Support identification and implementation of predictive maintenance opportunities based on equipment performance, failure patterns, and risk assessments.

• Assist in continuous monitoring of equipment reliability metrics such as MTBF, MTTR, and maintenance effectiveness.

3. Change Management & Continuous Improvement

• Support equipment-related changes through formal change control processes, ensuring compliance with GMP and site engineering standards.

• Assist with continuous improvement initiatives focused on improving asset availability, reliability, and lifecycle cost optimization.

4. Asset Information & Lifecycle Management (ISO 55000 Alignment)

• Maintain accurate and current asset information, including system specifications, User Requirement Specifications (URS), Functional Specifications (FS), P&IDs, equipment manuals, and SAP CMMS records, in accordance with asset lifecycle management principles.

• Support the Asset Information Management System by ensuring data integrity, traceability, and version control of engineering documentation.

• Assist in updating asset criticality assessments and understanding risk priority scores (RPNs) to support risk-based maintenance strategies.

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5. Projects & Shutdown Support

• Support engineering activities during planned shutdowns, including preparation, execution, and post-shutdown review.

• Assist in the execution of equipment-related projects funded through Capital Expenditure (CapEx) or Operational Expenditure (OpEx)

6. Compliance, Quality & Safety

• Ensure all engineering activities comply with GMP, EHS, and ISO 55000 asset management principles.

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  Support validation, qualification, and documentation activities where required (IQ/OQ/PQ support), in alignment with pharmaceutical quality systems. Support during internal and external audits related to equipment, asset management, and reliability

   

7. Completes any other duties/responsibilities assigned by senior management

Position Qualifications and Experience Requirements:

Education

• Bachelor’s degree in engineering (Chemical, Mechanical, Electrical) required or related field preferred

• Minimum of 2 years’ experience in the pharmaceutical, food, or chemical process industry.

Experience

• Experience in leading day-to-day decisions and personnel management.

• Knowledge of Six Sigma/Lean