Environmental Manager
Simtra BioPharma SolutionsBloomington, Indiana, United States · Posted 3 months agoDescription
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra? Because we:
Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.
Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.
This role:
The Environmental Manager provides strategic and operational leadership for all environmental programs, ensuring full regulatory compliance, advancing environmental performance, and driving a best-in-class ISO 14001-aligned Environmental Management System (EMS). This role is accountable for integrating environmental requirements into site operations, capital projects, and business growth initiatives while serving as the site’s subject matter expert and primary point of contact for regulatory agencies.
The Environmental Manager plays a critical role in risk identification, mitigation, and continuous improvement, ensuring environmental considerations are proactively embedded into decision-making across the organization. This position reports to the Associate Director of Environmental, Health, Safety, & Sustainability (EHS&S) and is 100% onsite at the Bloomington, Indiana facility.
The responsibilities:
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
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