Project Engineering, Associate Director
Listed on 2026-07-01
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Engineering
Regulatory Compliance Specialist, Operations Manager -
Management
Regulatory Compliance Specialist, Operations Manager
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. 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…
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