Project Engineering, Associate Director

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 (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

** 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.

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* Education:

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* ▪ Bachelor's degree in engineering (Chemical, Mechanical, Electrical, or related discipline) required.

▪ Advanced degree (MS or MBA) preferred.

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* Experience:

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* ▪ 10+ years of engineering experience in Biotech, Pharma, or regulated life sciences.

▪ 5+ years of…