Environmental Manager

Simtra BioPharma Solutions•Bloomington, IN

7d•Onsite

About The Position

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. 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.

Requirements

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

Nice To Haves

ISO 14001 Lead Auditor certification
Experience with EHS/ESG systems (e.g., VelocityEHS)
Multi-site or global operations experience
Zero 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

Responsibilities

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
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.
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.
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.
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).
Lead site sustainability initiatives (waste, energy, water)
Support ESG data collection, validation, and reporting
Align environmental strategy with broader business objectives.
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.
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.
Develop and deliver environmental training programs
Promote a strong environmental compliance culture and accountability
Support broader EHS initiatives and leadership engagement.