Overview
This role is accountable for the end-to-end execution of complex capital projects (T2&T3) within a cGMP-regulated environment, ensuring delivery aligned with business priorities, regulatory expectations, and CSL’s engineering and quality standards. The Project Engineering, Associate Director partners cross-functionally to translate strategic objectives into executable projects that enhance capacity, capability, and compliance across the manufacturing.
Role that this position reports to:
Head of Project Engineering
Main Responsibilities and Accountabilities:
Engineering Leadership
- Provide strategic and technical leadership across engineering disciplines, including process, mechanical, electrical, automation, and facilities.
- Ensure engineering solutions are robust, scalable, and compliant with cGMP, ISPE, and internal CSL standards.
- Review and approve key engineering deliverables (e.g., URS, design specifications, P&IDs, technical packages).
- Support technology transfers, process improvements, and facility expansions.
Project Delivery & Execution Excellence
- Lead the full lifecycle of capital projects (typically $1MM–$50MM+), from concept through design, procurement, construction, commissioning, and qualification (CQV).
- Translate business needs into clearly defined project scopes, timelines, and resource plans.
- Ensure consistent application of CSL project management standards, governance, and stage-gate processes.
- Proactively manage risks, issues, and change controls to ensure predictable project outcomes.
Quality & Compliance
- Ensure all project activities meet global regulatory requirements (FDA, EMA) and CSL Quality standards.
- Oversee commissioning, qualification, and validation strategies (IQ/OQ/PQ) to ensure inspection readiness.
- Partner with Quality and Validation to maintain a state of compliance throughout project execution.
Stakeholder Partnership
- Serve as a trusted partner to Engineering, Manufacturing, Quality, Supply Chain, Validation, and EHS functions.
- Provide clear, data-driven updates to senior leadership on project status, risks, and financial performance.
- Build and manage effective relationships with external partners, including EPC firms, OEMs, and contractors.
Safety, Health & Environment (EHS)
- Champion a zero-harm safety culture across all project phases, ensuring safety is the top priority in design and execution.
- Ensure compliance with all applicable EHS regulations (OSHA, EPA) and CSL global safety standards.
- Integrate safety-by-design principles (e.g., risk assessments, safety work permits) into engineering and project delivery.
- Lead contractor safety management, including prequalification, onboarding, and on-site oversight.
- Ensure robust incident prevention, reporting, and corrective action processes are in place.
- Partner with EHS to ensure safe execution during construction, commissioning, and startup activities.
Financial Stewardship
- Develop, manage, and forecast capital expenditure (CapEx) budgets in alignment with approved business cases.
- Drive disciplined cost management and identify opportunities for efficiency without compromising safety or quality.
- Ensure transparency in financial reporting and adherence to CSL's financial control
People Leadership & Culture
- Lead, coach, and develop a high-performing team of project engineers and external resources.
- Foster a culture of accountability, inclusion, safety, and continuous improvement consistent with CSL values.
- Build organizational capability through mentoring and talent development.
Operational Excellence
- Champion standardization and continuous improvement in project delivery processes.
- Apply Lean and Six Sigma principles to improve efficiency and reduce variability.
- Promote a strong safety culture and ensure EHS requirements are embedded in all project activities.
Education:
- Bachelor’s degree in engineering (Chemical, Mechanical, Electrical, or related discipline) required.
- Advanced degree (MS or MBA) preferred.
Experience:
- 10+ years of engineering experience in Biotech, Pharma, or regulated life sciences.
- 5+ years of experience leading capital projects in a cGMP-regulated manufacturing environment.
- Demonstrated success delivering complex, cross-functional projects.
- Strong knowledge of pharmaceutical manufacturing processes (e.g., fractionation, bulk processing, fill/finish, packaging).
- Expertise in critical utilities and facilities systems (HVAC, WFI, clean steam, process gases).
- Familiarity with automation and control systems (e.g., PLC, SCADA).
- Deep understanding of commissioning, qualification, and validation (CQV) lifecycle.
- Strategic thinker with the ability to translate complex engineering challenges into actionable programs.
Competencies:
- Demonstrated ability to lead through influence and drive alignment across functions.
- Strong decision-making and problem-solving skills in complex environments.
- Excellent communication skills with the ability to engage effectively at all levels of the organization.
- Strategic mindset with strong execution discipline.
- Financial Acumen & ROI-oriented mindset
- Commitment to CSL values, ethical behavior, inclusive teamwork, and modeling a positive, respectful culture.
- PMP (Project Management Professional)
- Lean Six Sigma (Green Belt or higher)
- Professional Engineer (PE) license
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/_](https://www.csl.com/) and CSL Plasma at [_https://www.cslplasma.com/_](https://www.cslplasma.com/).
