Simtra BioPharma Solutions
Environmental Manager
Bloomington, Indiana, United States · Director
Sponsorship not specifiedDetected 12 days ago
ComplianceAuditingGMPLeadershipCommunicationInternal Audit
About the role
- 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.
- 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.
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
- 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
- Lead environmental components of operational risk assessments for routine and non-routine work
- Partner with operations and engineering to evaluate environmental risks for new materials and processes.
- Interpret evolving requirements and proactively implement changes
Benefits
- 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 position reports to the Associate Director of Environmental, Health, Safety, & Sustainability (EHS&S) and is 100% onsite at the Bloomington, Indiana facility.
Company info
- 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.
- While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.
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