Project Engineering, Associate Director

Requirements

• ▪ 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 wi

Benefits

Additional Information

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.

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