Sr. Process Engineer (Aseptic Operation)

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.

Main Responsibilities and Accountabilities:

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 fill/finish operations including vial syringe and cartridge filling lines.

• Support isolator systems including design operation and lifecycle management.

• Provide engineering oversight for vial washer depyrogenation tunnel isolator capper and aseptic transfer technologies.

• Ensure robust aseptic practices and contamination control throughout filling and finishing 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 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.

• 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 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:

Education

• Bachelors degree in Engineering (Mechanical Chemical Biomedical or related field). Masters degree in Engineering or related field preferred

• 5 years of engineering experience in aseptic fill/finish biotech or pharmaceutical manufacturing.

• 4 years of experience with isolator Vial Washer Dehydrogenation Tunnel Isolator Capper.

Experience

• Experience in Aseptic processing expertise

• Technical problem-solving 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.

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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 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 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 Experience:

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