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 SupportProvide 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 MonitoringAnalyze 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 ImprovementSupport 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.undefined5. Projects & Shutdown SupportSupport 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 & SafetyEnsure all engineering activities comply with GMP, EHS, and ISO 55000 asset management principles.undefinedSupport 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 reliability7. Completes any other duties/responsibilities assigned by senior managementPosition Qualifications and Experience Requirements: EducationBachelor’s degree in engineering (Chemical, Mechanical, Electrical) required or related field preferredMinimum of 2 years’ experience in the pharmaceutical, food, or chemical process industry.ExperienceExperience 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 operationsProven ability to successfully lead projects from start to finish, ensuring they are completed on time, within budget, and meet high standards of petenciesContinuous Improvement & Lean/Six SigmaAnalytical Problem SolvingStakeholder Engagement & CommunicationCSL 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 Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits

Created: 2026-02-11