Production Engineer

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 preventative actions (CAPAs)

2. 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.

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

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 (Cap Ex) or Operational Expenditure (OpEx)

6. 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.

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

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

The expected base salary range for this position at hiring is $90,000 - $106,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors.

In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.