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.

• 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).

• 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.

• 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.

• 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.

• 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).

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

Completes any other duties/responsibilities assigned by senior management.

• 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 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 operations.
• Proven ability to successfully lead projects from start to finish, ensuring they are completed on time, within budget, and meet high standards of quality.

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

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law.

CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with…