HSE Program Lead – Campus Start-up Operations

Novartis; Durham (NC); On-site; USD 89,600 - 166,400; Full time

Job summary

Novartis in Durham is expanding its campus to include Aseptic Drug Product operations. This role will develop, implement, and track HSE deliverables and readiness prior to start-up, ensuring robust systems, controls, and regulatory compliance across construction and operations.

As Program Lead, you’ll drive safety programs, partner with internal teams and external providers, and foster a high-performance safety culture.

Qualifications

• 5+ years of HSE program development/management experience in manufacturing or lab settings.
• BS degree in Occupational Health & Safety, Chemical Engineering, or related field.
• Professional HSE certifications (e.g., CSP, CIH) preferred.
• Experience supporting design/startup of new ADP/LMO facilities and operations is desirable.
• Strong ability to influence and build relationships within a matrixed organization.
• Excellent communication and technical writing skills.

Responsibilities

• Lead implementation of HSE programs and controls for safe startup of ADP production.
• Integrate ADP HSE requirements into site-wide systems, processes and training.
• Partner with external providers and internal teams for safety performance.
• Develop and improve critical programs (Process Safety, Electrical Safety, Fire Protection, Emergency Response).
• Embed HSE practices to support production and research operations.
• Provide expert guidance for new equipment, processes, and tech transfers.
• Lead HSE impact assessments and manage changes for compliance and risk mitigation.
• Lead complex investigations and root-cause analyses.

Skills

HSE program management

Safety leadership

Regulatory knowledge

Communication skills

CGMP knowledge

Professional certifications (CSP/CIH)

Education

BS in Occupational Health & Safety or related field

Job description

Novartis in Durham is expanding its campus to include Aseptic Drug Product operations. This role will develop, implement, and track HSE deliverables and readiness prior to start-up, ensuring robust systems, controls, and regulatory compliance across construction and operations.

As Program Lead, you’ll drive safety programs, partner with internal teams and external providers, and foster a high-performance safety culture.