Senior EHS Manager

POSITION SUMMARY

The Senior EHS Manager is responsible for leading and executing the Environmental, Health & Safety strategy for ProMed. This role ensures compliance with OSHA, EPA, FDA (21 CFR Part 820), ISO 13485, ISO 14001, and ISO 45001 standards while fostering a proactive safety culture across operations.

The Senior EHS Manager partners cross-functionally with Quality, Engineering, Facilities, and Manufacturing as well as Pharma to integrate EHS requirements into all aspects of the business. The Senior EHS Manager ensures ProMed's brand, philosophy, systems, policies, and procedures are properly implemented and observed.

ESSENTIAL DUTIES & RESPONSIBILITIES

Position duties and responsibilities include, but are not limited to the following:

Regulatory Compliance & Governance

• Ensure compliance with federal, state, and local EHS regulations (OSHA, EPA, RCRA, DOT, etc.).
• Maintain all required environmental permits and regulatory reporting.
• Lead regulatory inspections, customer audits, and ISO audits.
• Oversee compliance with ISO 14001 and ISO 45001 management systems.
• Support FDA QSR (21 CFR Part 820) and ISO 13485 compliance as it relates to EHS.
• Manage EHS-related CAPAs and corrective actions.

Environmental Management

• Oversee hazardous waste management, chemical storage, and disposal programs.
• Manage air emissions, wastewater discharge, and stormwater compliance.
• Monitor and reduce environmental impact (waste, energy use, sustainability initiatives).
• Ensure proper ventilation and exhaust systems for cleanrooms and molding operations.

Occupational Health & Safety

• Develop, implement, and maintain site-wide safety programs.

• Conduct risk assessments, Job Hazard Analyses (JHA), and industrial hygiene monitoring.

• Manage programs including:

• Lockout/Tagout (LOTO)

• Machine guarding

• Ergonomics

• Confined space

• Respiratory protection

• Hazard communication

• Lead incident investigations and root cause analysis.

• Track and improve safety KPIs (TRIR, DART, LTIR).

• Develop emergency response and business continuity plans.

Cleanroom & Medical Device Manufacturing Support

• Ensure safe handling of medical-grade polymers, solvents, and sterilization chemicals.
• Partner with Quality and Engineering on process FMEAs and risk assessments.
• Monitor employee exposure levels and maintain industrial hygiene programs.
• Support new equipment installation and process validation from an EHS perspective.

Leadership & Culture

• Lead and develop the EHS team.
• Drive safety culture initiatives and employee engagement programs.
• Deliver safety training programs and maintain compliance records.
• Prepare and present EHS metrics to executive leadership.
• Manage EHS budget and capital improvement projects.
• Establishes and cultivates a network of support (laboratory, quality, manufacturing, engineering, sales, and marketing) to facilitate completion of assignments.

This job also requires performing other duties as assigned.

QUALIFICATION, EDUCATION & EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's degree in environmental health & safety, Environmental Engineering, Industrial Hygiene, Occupational Safety, or related field required.
• 8-12+ years of progressive EHS experience in manufacturing.
• 3-5+ years in medical device or FDA-regulated environment preferred.
• Experience leading regulatory inspections and ISO audits required.
• Strong knowledge of OSHA 29 CFR 1910, EPA regulations, RCRA, and DOT requirements.
• Familiarity with FDA QSR (21 CFR Part 820) and ISO 13485.
• Understanding of ISO 14001 and ISO 45001 management systems.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Proven leadership and change management ability.

Preferred:

• Master's degree preferred.
• Experience in cleanroom operations is strongly preferred.
• Certified Safety Professional (CSP)
• Certified Industrial Hygienist (CIH)
• Certified Hazardous Materials Manager (CHMM)
• ISO 14001 / ISO 45001 Lead Auditor
• OSHA 30 or OSHA 500
• Experience in injection molding, precision manufacturing, or sterilization processes preferred.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job.

• Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
• Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
• The noise level in the work environment is usually minor;
• Duties are performed indoors;
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS

While performing the duties of this job:

• The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
• Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
• The position requires the individual to meet multiple demands from several people and interact with internal and external people;
• Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
• Employee may have duties involving walking on even or uneven surfaces;
• Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
• Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment;
• It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently.
• Employee must see and hear on a continuous basis as well as speak frequently;

Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.

1st Shift