Site HSE Specialist
Novartis
June 27, 2026
On-site
Durham, NC
Corporate Functions
Role Summary
- Supports expansion of the Durham campus for Aseptic Drug Product operations by developing, implementing, and tracking HSE deliverables and operational readiness needs.
Key Responsibilities
- Lead implementation of robust HSE programs and controls to enable safe, compliant startup of ADP production operations.
- Integrate ADP-specific HSE requirements into site-wide systems, processes, and training.
- Partner with external providers and internal teams to deliver safety performance across construction and operations.
- Develop and continuously improve occupational safety programs (e.g., Process Safety, Electrical Safety, Fire Protection, Emergency Response).
- Collaborate cross-functionally to embed HSE practices supporting reliable commercial production and research operations.
- Provide expert HSE guidance for new equipment, processes, and technology transfers.
- Lead HSE impact assessments and manage change for compliance and risk mitigation.
- Lead complex investigations with root cause analysis and resolution.
- Use HSE data, metrics, and insights for continuous improvement.
- Champion a high-performance safety culture through training, governance, audits, regulatory engagement, and stakeholder collaboration.
Essential Requirements
- 5+ years of HSE program development/management in a manufacturing/laboratory environment (biopharmaceutical preferred); strong HSE technical knowledge.
- BS degree or higher in Occupational Health & Safety, Chemical Engineering, or related field.
- Professional HSE certifications (e.g., CSP, CIH) or strong desire to attain.
- Experience supporting design and startup of new ADP/LMO facilities and manufacturing operations (e.g., PHA, P&ID/design review, HSE operational readiness) highly desired.
- Strong influencer/relationship-building skills in a matrixed organization.
- Excellent communication and technical writing; strong interpersonal skills and ability to manage multiple tasks in a fast-paced environment.
- Knowledge of cGMP manufacturing regulations and requirements aligned with effective EHS programs.
- Supports expansion of the Durham campus for Aseptic Drug Product operations by developing, implementing, and tracking HSE deliverables and operational readiness needs.
Key Responsibilities
- Lead implementation of robust HSE programs and controls to enable safe, compliant startup of ADP production operations.
- Integrate ADP-specific HSE requirements into site-wide systems, processes, and training.
- Partner with external providers and internal teams to deliver safety performance across construction and operations.
- Develop and continuously improve occupational safety programs (e.g., Process Safety, Electrical Safety, Fire Protection, Emergency Response).
- Collaborate cross-functionally to embed HSE practices supporting reliable commercial production and research operations.
- Provide expert HSE guidance for new equipment, processes, and technology transfers.
- Lead HSE impact assessments and manage change for compliance and risk mitigation.
- Lead complex investigations with root cause analysis and resolution.
- Use HSE data, metrics, and insights for continuous improvement.
- Champion a high-performance safety culture through training, governance, audits, regulatory engagement, and stakeholder collaboration.
Essential Requirements
- 5+ years of HSE program development/management in a manufacturing/laboratory environment (biopharmaceutical preferred); strong HSE technical knowledge.
- BS degree or higher in Occupational Health & Safety, Chemical Engineering, or related field.
- Professional HSE certifications (e.g., CSP, CIH) or strong desire to attain.
- Experience supporting design and startup of new ADP/LMO facilities and manufacturing operations (e.g., PHA, P&ID/design review, HSE operational readiness) highly desired.
- Strong influencer/relationship-building skills in a matrixed organization.
- Excellent communication and technical writing; strong interpersonal skills and ability to manage multiple tasks in a fast-paced environment.
- Knowledge of cGMP manufacturing regulations and requirements aligned with effective EHS programs.