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 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.

Competencies

• 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 Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.

The expected base salary range for this position at hiring is $78,000- $98,000. 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.

CSL 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.