Production Engineer

Responsibilities

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 preventative actions (CAPAs).

Maintenance & Asset Health Monitoring

• Analyze asset health data by reviewing corrective maintenance (CM) and preventative 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.

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.

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.

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).

Compliance, Quality, & Safety

• Ensure all engineering activities comply with GMP, EHS, and ISO 55000 asset management principles.
• Author, review, and approve SOPs, Change Controls, deviations, and CAPAs.
• 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.

Completes any other duties/responsibilities assigned by senior management.

Qualifications

Education

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

Experience

• Minimum of 2 years' experience in the pharmaceutical, food, or chemical process industry.
• Experience in leading day-to-day decisions and personnel management.
• Knowledge of Six Sigma/Lean principles is a plus.
• Strong knowledge of cGMPs and their application in manufacturing.
• Proven ability to successfully lead projects from start to finish, ensuring they are completed on time, within budget, and meet high standards of quality.

Competencies

• Continuous Improvement & Lean/Six Sigma
• Analytical Problem Solving
• Stakeholder Engagement & Communication