Environmental Manager
Simtra BioPharma Solutions · Bloomington, IN · 2 wk ago
On-siteManagementFull-time
Regulatory Strategy & Compliance Leadership
- Own and ensure compliance with all federal, state, and local environmental regulations (e.g., EPA, IDEM)
- Serve as the site’s primary regulatory liaison; manage inspections, audits, and agency communications
- Interpret evolving requirements and proactively implement changes
- Maintain and optimize environmental permits (air, water, waste) and ensure adherence to conditions
- Lead environmental compliance risk assessments and mitigation strategies
Environmental Management System (ISO 14001)
- Lead development, implementation, and continuous improvement of an ISO 14001-aligned EMS
- Define and manage environmental aspects/impacts with risk prioritization
- Drive internal audit programs and support external certification audits
- Establish and track environmental objectives, targets, and KPIs
- Integrate EMS requirements into site operations, procedures, and culture
Operational Risk & Chemical Management
- Lead environmental components of operational risk assessments for routine and non-routine work
- Oversee chemical management programs including SDS compliance, approvals, and inventory controls
- Partner with operations and engineering to evaluate environmental risks for new materials and processes
Waste Management & Compliance
- Oversee hazardous and non-hazardous waste programs in compliance with RCRA and applicable regulations
- Ensure proper waste characterization, storage, labeling, and disposal
- Manage vendor relationships and ensure compliant transport and disposal
- Drive waste minimization and cost reduction initiatives
Air, Water & Environmental Programs
- Manage air emissions programs, including permitting, reporting, and monitoring
- Oversee wastewater and stormwater programs and permit compliance
- Identify opportunities to improve environmental performance and reduce footprint
- Ensure accurate and timely environmental reporting (TRI, Tier II, emissions inventories)
Sustainability & ESG Integration
- Lead site sustainability initiatives (waste, energy, water)
- Support ESG data collection, validation, and reporting
- Align environmental strategy with broader business objectives
Project & Change Management
- Provide environmental oversight for capital projects, expansions, and new product introductions
- Ensure environmental requirements are incorporated into design, commissioning, and change control
- Support environmental impact assessments for new processes and technologies
Cross-Functional Leadership
- Partner with Engineering, Facilities, Operations, Supply Chain, and Quality
- Provide practical, risk-based environmental guidance to influence decisions
- Support client and regulatory audits with clear, defensible practices
Training, Culture & Engagement
- Develop and deliver environmental training programs
- Promote a strong environmental compliance culture and accountability
- Support broader EHS initiatives and leadership engagement
Required qualifications:
- BS degree in Environmental Science, Environmental Engineering, Occupational Health & Safety, Industrial Hygiene, or related field required
- 5-8 years of environmental compliance experience in manufacturing (pharmaceutical/CDMO environment)
- 8+ years experience in environmental health and safety in pharmaceutical manufacturing considered in lieu of degree
- Demonstrated ownership of environmental programs, permits, and regulatory interactions
- Strong knowledge of RCRA, Clean Air Act, and Clean Water Act
- Experience with ISO 14001 or similar management systems
- Ability to operate both strategically and hands-on in a complex environment
- Strong regulatory interpretation and application skills
- Ability to lead audits and engage with regulators
- Risk-based decision-making and problem-solving
- Strong project management and organizational skills
- Effective communication and influence across all levels
- ISO 14001 Lead Auditor certification
- Experience with EHS/ESG systems (e.g., VelocityEHS)
- Multi-site or global operations experience
- No significant environmental compliance violations
- Successful regulatory inspections and audit outcomes
- ISO 14001 audit readiness and performance
- Reduction in environmental incidents and risks
- Timely and accurate environmental reporting
- Progress against sustainability and ESG targets
- Closure and effectiveness of environmental CAPAs