Senior HSE Director - Start-Up Manufacturing

Biopharma Careers; Fogelsville (Lehigh County); On-site; USD 164,000 - 240,000; Full time

Job summary

Lilly is designing and building a Next-Generation Parenteral and Device Assembly/Packaging Facility in Lehigh Valley. The Senior Director-HSE will lead the Health, Safety, and Environmental function for construction, start-up, and ongoing manufacturing operations, shaping strategy and ensuring regulatory compliance and an injury-free workplace.

The role requires extensive HSE expertise, strong leadership, and the ability to partner across Lilly’s network.

Qualifications

• Bachelor of Science in a scientific, engineering, or HSE discipline.
• Significant HSE experience, including experience in manufacturing environments.
• Experience with CAPA systems for HSE changes, deviations, and corrective actions.
• Strong written and verbal communication skills in English.
• On-site presence required.

Responsibilities

• Serve as a member of the Site Lead Team, contributing to site strategy, priorities, and performance across safety, quality, and operational excellence.
• Build, lead, and sustain a high-performing HSE organization through clear expectations, talent development, succession planning, and accountability for results.
• Establish and sustain an injury free workplace by advancing a strong safety culture, risk awareness, and disciplined execution of HSE programs.
• Develop, implement, and continuously improve the site HSE management system.
• Ensure compliance with internal and external HSE requirements, including permitting, regulatory commitments, corporate standards, and site procedures.
• Build and maintain effective relationships with HSE regulators and lead site interactions during audits and inspections.
• Develop and execute the site HSE roadmap in alignment with business priorities and start-up milestones.
• Partner with Corporate HSE and collaborate with HSE peers across Lilly manufacturing sites to share best practices and strengthen site capability.
• Establish local employee health services in collaboration with Human Resources.
• Develop, establish, and sustain systems, processes, and programs that support the transition from construction to start-up and routine operations.
• Partner with construction and design-build firms to ensure a smooth and compliant handoff from construction to start-up.
• Provide leadership and technical direction for all HSE activities at the site, including industrial hygiene, industrial safety, and environmental programs.
• Understand and support HSE event, CAPA, and change control processes, and influence application of the hierarchy of controls to reduce risk and improve outcomes.
• Leverage knowledge of severe injury risk to drive prevention, strengthen awareness, and increase HSE capability across the site.
• Ensure prompt closure of regulatory commitments and site actions related to HSE observations, events, and inspections.

Skills

HSE leadership

CAPA systems

Regulatory compliance

GMP experience

Cross-functional leadership

Change control

Industrial hygiene

Industrial safety

Environmental programs

Education

BSc in science/engineering/HSE

Job description

Lilly is designing and building a Next-Generation Parenteral and Device Assembly/Packaging Facility in Lehigh Valley. The Senior Director-HSE will lead the Health, Safety, and Environmental function for construction, start-up, and ongoing manufacturing operations, shaping strategy and ensuring regulatory compliance and an injury-free workplace.

The role requires extensive HSE expertise, strong leadership, and the ability to partner across Lilly’s network.