remote
Associate Director, Project Engineering - CSL Plasma
Software Engineer
Lead end‑to‑end execution of complex T2/T3 capital projects in a cGMP environment, aligning technical delivery with business priorities, regulatory expectations, and engineering quality standards.
About the role
Key Responsibilities
- Plan, direct, and deliver multi‑phase capital projects (T2/T3) from concept through commissioning within a cGMP‑regulated facility.
- Translate strategic objectives into detailed project scopes, schedules, budgets, and risk mitigation plans.
- Coordinate cross‑functional teams—including engineering, quality, validation, and operations—to ensure seamless integration and compliance.
- Maintain alignment with regulatory requirements (FDA, EMA) and internal engineering and quality standards throughout the project lifecycle.
- Monitor project performance, manage change orders, and report status to senior leadership, ensuring on‑time and on‑budget delivery.
Requirements
- Bachelor’s degree in Engineering or related field; advanced degree preferred.
- 10+ years of experience managing complex capital projects in a cGMP or highly regulated environment.
- Proven expertise in project management methodologies, risk assessment, and regulatory compliance.
- Strong leadership and communication skills to influence and align diverse stakeholder groups.
- Demonstrated ability to drive continuous improvement and deliver projects that enhance capacity, capability, and compliance.