Director OF Project Management

Role 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. 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. Qualifications 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 leading capital projects in a cGMP‑regulated manufacturing environment; proven success delivering complex, cross‑functional projects. Expertise in pharmaceutical manufacturing processes (e.g., fractionation, bulk processing, fill/finish, packaging), critical utilities and facilities systems (HVAC, WFI, clean steam, process gases), automation and control systems (PLC, SCADA), and commissioning, qualification, and validation (CQV) lifecycle. Strategic thinker with the ability to translate complex engineering challenges into actionable programs. Competencies: Proven ability to lead through influence, strong decision‑making and problem‑solving skills, excellent communication across all levels, strategic mindset with execution discipline, financial acumen and ROI orientation, commitment to CSL values, ethical behavior, inclusive teamwork, and positive culture modeling. Certifications: PMP (Project Management Professional), Lean Six Sigma (Green Belt or higher), Professional Engineer (PE) license. Expected base salary range: $173,000 – $205,000. Total compensation may include incentive and equity. Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit #J-18808-Ljbffr