Senior Production Engineer, Fractionation

Position Purpose:
The Senior Production Engineer provides technical leadership and strategic engineering support to pharmaceutical manufacturing operations, ensuring optimal asset performance, reliability, and compliance throughout the asset lifecycle. This role drives risk-based asset management strategies
in alignment with ISO 55000 principles, GMP requirements, and business objectives, while partnering with Production, Maintenance, Quality, and Capital Projects teams.

Reporting Relationships:
▪ Role that this position reports to:
Main Responsibilities and Accountabilities: List the roles and responsibilities of the position.

1) Process & Equipment Engineering
▪ Provide senior-level frontline engineering support for complex equipment issues, leading structured troubleshooting and failure investigations. Such as, but not limited to separation, extraction, purification and filling processes.
▪ Support fractionation, bulk or fill finish systems including design, operation, and lifecycle management.
▪ Provide engineering oversight for centrifuges, filter presses, chromatography
columns, ultra-filtration and diafiltration, clean-in-place, clean out of place, aseptic transfer technologies etc
▪ Ensure robust GMP practices and contamination control throughout operations.
▪ Lead Root Cause Analysis (RCA) using recognized methodologies (e.g., FMEA, 5- Why, Fishbone) and ensure effective implementation of CAPAs.
▪ Define and drive equipment reliability strategies to improve availability,
performance, and lifecycle cost.

2) Maintenance & Asset Health Monitoring
▪ Develop, review, and optimize preventive and predictive maintenance strategies based on asset criticality, historical performance, and condition monitoring data.
▪ Analyze asset health using CMMS data (SAP), including MTBF, MTTR, OEE
contributors, and maintenance effectiveness KPIs.
▪ Champion predictive maintenance technologies and condition-based monitoring to reduce unplanned downtime and asset risk.

3) Change Management & Continuous Improvement
▪ Lead equipment-related changes through formal change control processes and investigations, ensuring GMP compliance, data integrity, and controlled risk.
▪ Drive continuous improvement initiatives focused on asset reliability, compliance, and operational efficiency, aligned with site and corporate asset management objectives.
▪ Work to improve equipment reliability as measured by Operational Equipment
Effectiveness (OEE).
▪ Mentor junior engineers and technicians in reliability engineering, asset
management principles, and GMP-compliant engineering practices.
▪ Rotation between value streams
▪ Provide technical training on aseptic equipment and best practices.

4) Asset Information & Lifecycle Management (ISO 55000 Alignment)
▪ Own and govern asset information across the lifecycle, ensuring integrity,
traceability, and alignment with ISO 55000 Asset Information Management
requirements, including URS, FS/DS, P&IDs, equipment files, and SAP CMMS
records.
▪ Lead asset criticality assessments and risk-based prioritization using failure
modes, risk priority numbers (RPNs), and business impact analysis to support
maintenance and investment decisions.
▪ Ensure alignment between asset performance objectives, site asset management plans, and production demand.

5) Projects & Shutdown Support
▪ Lead equipment-related projects funded through Capital Expenditure (CapEx) or Operational Expenditure (OpEx), including scope definition, business case
development, risk assessment, and execution.
▪ Provide engineering leadership during planned shutdowns, including scope
planning, resource coordination, execution oversight, and post-shutdown
performance review.
▪ Support equipment lifecycle decisions, including refurbishment, upgrade, and
replacement strategies based on asset condition and business risk.

6) Compliance, Quality & Safety
▪ Ensure engineering activities comply with GMP, EHS, and ISO 55000/55001
requirements.
▪ Author, review, and approve SOPs/, change controls, deviations, investigations and CAPAs.
▪ Lead and support qualification and validation activities (IQ/OQ/PQ), ensuring
engineering documentation supports regulatory inspections and audits.
▪ Act as a subject matter expert 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: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.

Education
▪ Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or
related field).
▪ Master’s degree in Engineering or related field preferred

Experience
▪ 5+ years of engineering experience in pharmaceutical manufacturing.
▪ Experience in Aseptic, Bulk, or Fractionation processing expertise
▪ Technical problem-solving, investigation and root cause analysis
▪ Knowledge of Six Sigma/Lean principles is a plus.
▪ Strong knowledge of sterile filling operations, aseptic techniques, and
contamination control.
▪ Proven ability to successfully lead projects from start to finish, ensuring
they are completed on time, within budget, and meet high standards of
quality.
▪ Proven experience supporting cGMP environments and regulatory
inspections.
▪ Knowledge of Six Sigma/Lean principles is a plus.

Competencies
▪ Strategic Planning & Execution
▪ Continuous Improvement & Lean/Six Sigma
▪ Team Leadership & Development
▪ Analytical Problem Solving
▪ Stakeholder Engagement & Communication
▪ Cross-functional collaboration

About CSL Behring

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.