CapEx Portfolio Lead

Role that this position reports to

Head of Project Engineering

• 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.

• 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.

• 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.

• 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.

• 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.

• Develop, manage, and forecast capital expenditure (Cap Ex) 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.

• 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.

• 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.

• Bachelor’s degree in engineering (Chemical, Mechanical, Electrical, or related discipline) required.
• Advanced degree (MS or MBA) preferred.

• 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…