Senior Specialist Safety & Environment

Role Overview

As a core member of the Site Environmental, Health, and Safety (EHS) team, the Senior Specialist of Safety & Environment will provide vital technical leadership, risk management, and project ownership for operating departments at our Rahway site. This role focuses heavily on identifying, assessing, and mitigating biosafety and industrial hygiene hazards across research, development, and pilot-scale operations. You will partner closely with laboratory and clinical manufacturing departments to design, implement, and maintain compliant biological containment and technical safety solutions.

Impact and Responsibilities

You will serve as the site's primary technical resource for biological safety compliance, ensuring daily operations meet site and regulatory standards. By collaborating with scientists, facilities engineering, and site leadership, you will cultivate a robust safety culture, streamline biological material handling, and align biosafety protocols with fast-paced site business priorities.

Primary Activities

• Lead the implementation and continuous improvement of site Biosafety programs, policies, and standard operating procedures (SOPs).
• Develop and deliver specialized biosafety training curricula (e.g., bloodborne pathogens and biological waste management).
• Conduct comprehensive biological risk assessments for new research projects, material use, and pilot-scale processes.
• Participate in industrial hygiene monitoring (airborne agents, chemical exposures, noise, etc.) and prepare reports pairing IH and biological risk mitigation strategies.
• Provide hands-on oversight for biological containment systems, including Biosafety Cabinets (BSCs), laminar flow hoods, and custom containment engineering controls.
• Perform routine laboratory safety audits, containment reviews, and technical coaching for laboratory personnel and contractors.
• Actively support and participate in the Institutional Biosafety Committee (IBC), implementing site policies, reviewing biological risk assessments, and implementing committee directives.
• Partner with the site on capital projects and facility modifications to ensure proper HVAC, pressure cascades, and waste systems are integrated into biological spaces.
• Support management of change (MOC) reviews, incident investigations, and Process Hazard Analyses (PHA) involving biological and chemical hazards.
• Provide technical guidance on the handling, inactivation, and disposal of biological and hazardous waste.
• Support site emergency response planning for potential biological spills or exposure incidents.

Position Qualifications

• Bachelor's degree (BS) in Microbiology, Molecular Biology, Biochemistry, Biosafety, Industrial Hygiene, Occupational Health & Safety, or a closely related scientific/engineering discipline. A relevant master's degree is highly preferred.
• Minimum 8+ years of applied professional experience in EHS, with at least 4+ years dedicated directly to biosafety, biological containment, or laboratory safety within a pharmaceutical, biotechnology, academic research, or clinical environment.
• Demonstrated expertise in implementing biosafety containment strategies, conducting biological risk assessments, and managing laboratory safety protocols.
• Hands-on experience with industrial hygiene monitoring practices (airborne particulate sampling, chemical exposure assessment, and ventilation measurements).
• Outstanding technical writing and verbal skills; proven ability to translate complex microbiological and chemical risk data into clear, actionable advice for non-EHS stakeholders.
• Critical thinking and analytical skills to resolve complex containment and process safety challenges.
• Self-motivated and able to lead site-wide biosafety initiatives independently while escalating program-level decisions appropriately.

Preferred Experience and Skills

• Hands-on experience with biosafety technical work in laboratory and pilot-scale settings (biosafety risk assessments, containment recommendations, biosafety cabinet oversight, biological waste handling).
• Practical experience providing general EHS support in pilot-scale and laboratory environments, including safety inspections, contractor oversight, emergency response support, and corrective action tracking.
• Relevant professional certifications preferred: CBSP/RBP, CIH, ASP/CSP, or equivalent. Note: certification requirements can be adjusted based on hiring needs.
• Experience preparing for and hosting regulatory inspections (e.g., OSHA) and drafting technical responses to regulatory inquiries.
• Experience utilizing specialized EHS data systems, incident tracking software, and occupational health databases.