Site HSE Specialist
Listed on 2026-07-03
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Summary
This role is responsible for supporting the expansion of the Durham campus to include Aseptic Drug Product operations. It will develop, implement, and track completion of HSE deliverables and needs — such as design input, construction safety, and HSE operational readiness prior to the start of operations — to ensure robust implementation of HSE systems, programs, and controls before operations begin.
Key Responsibilities- Lead the implementation of robust HSE programs and controls to enable safe and compliant start‑up of ADP production operations.
- Integrate ADP‑specific HSE requirements into site‑wide systems, processes, and training frameworks.
- Partner with external providers and internal teams to deliver world‑class safety performance across construction and operations.
- Drive occupational safety excellence by developing and continuously improving critical programs (e.g., Process Safety, Electrical Safety, Fire Protection, Emergency Response).
- Collaborate cross‑functionally to embed HSE practices that support reliable commercial production and research operations.
- Provide expert HSE guidance for new equipment, processes, and technology transfers, ensuring safe and efficient implementation.
- Lead HSE impact assessments and manage change to ensure compliance and risk mitigation across site operations.
- Act as a trusted technical expert, leading complex investigations and ensuring effective root cause analysis and resolution.
- Leverage HSE data, metrics, and insights to drive continuous improvement and deliver strong business outcomes.
- Champion a high‑performance safety culture through training, governance, audits, regulatory engagement, and strong stakeholder collaboration.
- 5+ years of HSE program development/management experience in a manufacturing or laboratory environment (preferably within the biopharmaceutical industry); strong technical knowledge across HSE disciplines.
- Prior experience supporting the design and startup of new ADP/LMO facilities and manufacturing operations (e.g., PHA, P&/design documentation review, HSE operational readiness) highly desired.
- Strong influencer with the ability to work effectively and build relationships across a matrixed organization.
- Excellent communication and technical writing skills.
- Outstanding interpersonal skills for collaboration, creativity in problem solving, and the ability to plan and perform multiple tasks with high quality in a fast‑paced work environment.
- Knowledge of cGMP manufacturing regulations and requirements in conjunction with the delivery of effective EHS programs.
- BS degree or higher in Occupational Health & Safety, Chemical Engineering, or a related field.
- Professional HSE certifications (e.g., CSP, CIH) or a strong desire to attain them.
Salary range: $89,600.00 to $ per year, determined by skills, experience, and performance. The final offer is reviewed periodically. Compensation will also include a performance‑based cash incentive and, depending on the level, eligibility for annual equity awards. Eligible US employees receive a comprehensive benefits package that includes health, life, and disability benefits; a 401(k) with company contribution and match; and a generous time‑off package (vacation, personal days, holidays, and other leaves).
EqualEmployment Opportunity Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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