Senior Specialist, Environmental Health & Safety

Job Title: Senior Specialist, Environmental Health & Safety

 

Role Level: Individual Contributor (IC)

 

Supervisor/Manager Title: Senior Global Manager, Manufacturing Engineering

 

Job Location & Environment: Irvine, CA – Corporate Office, Cleanroom Manufacturing, and Warehouse

 

Job Description Summary: Serve as the site Environmental Health & Safety (EH&S) lead for JenaValve’s headquarters and manufacturing operations. This individual contributor role is responsible for building, implementing, and sustaining EH&S programs that support regulatory compliance, safe manufacturing and laboratory operations, facility readiness, and business growth in a regulated medical device environment. The role partners closely with Operations, Manufacturing Engineering, Facilities, Quality, R&D, Clinical, Regulatory, and corporate functions to support scale-up, risk reduction, and continuous improvement.

 

Job Responsibilities:

Core Responsibilities

• Lead site EH&S programs to ensure compliance with OSHA, Cal/OSHA, EPA, and other applicable local, state, and federal requirements.

• Develop, implement, and maintain EH&S policies, procedures, training, inspections, audits, risk assessments, and corrective actions that support safe manufacturing, laboratory, cleanroom, and facility operations.

• Serve as the site EH&S subject matter expert and partner cross-functionally with Operations, Manufacturing Engineering, Facilities, Quality, R&D, Clinical, Regulatory, and corporate teams to support scale-up, new processes, equipment and facility changes, and inspection readiness.

• Lead incident investigations, root cause analysis, emergency preparedness, contractor safety, compliance documentation, and EH&S performance tracking to strengthen site safety culture and scalable compliance systems.

Specialized Program Ownership

• Own chemical and industrial hygiene programs, including hazard communication, hazardous waste, aldehyde and glutaraldehyde exposure control, air monitoring, ventilation verification, respiratory protection, medical surveillance support, and safe chemical storage, labeling, use, and disposal.

• Manage biosafety and regulated waste programs for animal-origin materials, porcine tissue, returned used medical devices, biologic or potentially infectious waste, and decontamination activities, including containment, risk assessment, employee protection, waste characterization, and documentation in coordination with Quality, Clinical, and Regulatory teams.

• Lead environmental compliance activities related to hazardous waste, industrial wastewater, sewer discharge, permit coordination, monitoring, reporting, and agency interactions, including readiness for scale-triggered requirements such as Hazardous Materials Business Plan, CERS, EPCRA, and air permitting.

• Support EH&S requirements for specialized manufacturing processes, including sterilization operations, nitinol processing, laser cutting, electropolishing, solvent use, compressed gases, and cleanroom operations, through risk assessment, engineering controls, safe work practices, and training.

Required Education and Experience:

• Bachelor’s degree in Environmental Health & Safety, Environmental Science, Occupational Safety, Engineering, Industrial Hygiene, or a related technical discipline preferred.

• Minimum 5 years of EH&S experience in a regulated manufacturing environment, preferably in medical device, biotechnology, pharmaceutical, or other highly regulated operations.

• Demonstrated ability to build and manage EH&S programs with minimal oversight, including risk assessment, incident investigation, corrective actions, inspections, training, and regulatory compliance activities.

• Experience with chemical safety, industrial hygiene, hazardous waste, biosafety, and environmental compliance in California manufacturing or laboratory environments strongly preferred.

• Experience supporting specialized operations such as cleanrooms, sterilization, returned-product decontamination, industrial wastewater, or metal-processing hazards is preferred.

• Working knowledge of OSHA, Cal/OSHA, EPA, hazardous materials and waste requirements, and related environmental permitting and reporting obligations required.

• Professional certifications such as OSHA 30, HAZWOPER, CHMM, CSP, or similar are preferred.

 

Skills and Abilities Required for This Job:

• Strong communication, technical writing, organization, and follow-through skills.

• Ability to work independently, prioritize effectively, and drive multiple initiatives to completion in a fast-paced, evolving environment.

• Strong problem-solving, risk assessment, and practical decision-making skills.

• Strong cross-functional collaboration skills and ability to influence safe, compliant practices across the organization.

 

Physical Requirements:

• Ability to stand, walk, and move throughout manufacturing, laboratory, cleanroom, and office environments for extended periods of time.
• Ability to lift and carry materials, safety equipment, or supplies weighing up to 25–35 pounds and safely wear required personal protective equipment (PPE) including respirators, safety glasses, gloves, and cleanroom garments.