The Head of Project Engineering role is responsible for leading the end-to-end execution of
strategic capital projects that expand manufacturing capacity and capability. This role ensures
delivery of cGMP-compliant equipment and facilities that meet FDA and global regulatory
standards, while aligning with enterprise-wide strategic objectives. The incumbent will lead cross-
functional teams through the full project lifecycle-from scoping and design through
procurement, construction, qualification, and turnover to commercial operations.
Main Responsibilities and Accountabilities: List the roles and responsibilities of the position
1 Project Leadership & Execution: § Lead multi-disciplinary teams through all phases of project delivery, ensuring alignment with global and local strategic goals. § Oversee the development, procurement, construction, and qualification of new equipment and facilities to meet production throughput demands. § Ensure projects are executed in alignment with CSL's Operating System (COS), Site Management System (SMS), and global engineering standards. § Ensure projects are delivered on time, within budget, and in compliance with cGMP and regulatory requirements.
2 Strategic Alignment & Governance: § Ensure all initiatives are aligned with business objectives and the strategic philosophy of the organization. § Translate CSL's long-term capacity and technology strategies into executable site-level project plans. § Provide regular updates to senior site leadership and global steering committees, including financial status, schedules, risks, and progress summaries.
3 Compliance & Quality § Ensure all project activities result in facilities and processes suitable for FDA and global regulatory approval. § Partner with Quality Assurance and Regulatory Affairs to support validation and submission requirements.
4 Resource Management § Manage internal and external resources, including engineering firms, contractors, and consultants. § Build and maintain high-performing project teams with clear accountability and performance metrics.
5 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 (Chemical, Mechanical, Electrical) required, a master's preferred. § Minimum of ten years' experience in the pharmaceutical, food, or chemical process industry. § 5+ years' experience in engineering and/or leadership roles in project management/engineering, in the chemical industry
Experience
§ Experience in process control, automation, construction, quality, project management, safety, and engineering. § PMP certification preferred. § Collaborative team player with decision-making and influencing skills. § Strong understanding of cGMPs and FDA regulations. § Knowledgeable in project management principles, risk management, and critical path analysis. § Experience with biologics, sterile manufacturing, and advanced modalities (e.g., ADCs, mRNA). § Familiar with validation, CMC, and regulatory submission requirements. § Financial acumen in managing multimillion-dollar budgets. § Ability to lead cross-functional teams and manage multiple projects. § Strategic thinker with a proactive approach to problem-solving.
Competencies
§ Strategic Project Leadership § Technical Engineering Expertise § Capital Planning and Execution § Stakeholder and Cross-Functional Collaboration § Compliance and Risk Management § Operational Excellence § Communication and Executive Influence
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 (https://www.csl.com/careers/your-well-being) .
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 .
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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. https://www.cslbehring.com/careers/eeo-statement
