Environmental Manager

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 LeadershipOwn 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 communicationsInterpret evolving requirements and proactively implement changesMaintain and optimize environmental permits (air, water, waste) and ensure adherence to conditionsLead environmental compliance risk assessments and mitigation strategiesEnvironmental Management System (ISO 14001)Lead development, implementation, and continuous improvement of an ISO 14001-aligned EMSDefine and manage environmental aspects/impacts with risk prioritizationDrive internal audit programs and support external certification auditsEstablish and track environmental objectives, targets, and KPIsIntegrate EMS requirements into site operations, procedures, and culture. Operational Risk & Chemical ManagementLead environmental components of operational risk assessments for routine and non-routine workOversee chemical management programs including SDS compliance, approvals, and inventory controlsPartner with operations and engineering to evaluate environmental risks for new materials and processes. Waste Management & ComplianceOversee hazardous and non-hazardous waste programs in compliance with RCRA and applicable regulationsEnsure proper waste characterization, storage, labeling, and disposalManage vendor relationships and ensure compliant transport and disposalDrive waste minimization and cost reduction initiatives. Air, Water & Environmental ProgramsManage air emissions programs, including permitting, reporting, and monitoringOversee wastewater and stormwater programs and permit complianceIdentify opportunities to improve environmental performance and reduce footprintEnsure accurate and timely environmental reporting (TRI, Tier II, emissions inventories). Sustainability & ESG IntegrationLead site sustainability initiatives (waste, energy, water)Support ESG data collection, validation, and reportingAlign environmental strategy with broader business objectives. Project & Change ManagementProvide environmental oversight for capital projects, expansions, and new product introductionsEnsure environmental requirements are incorporated into design, commissioning, and change controlSupport environmental impact assessments for new processes and technologies. Cross-Functional LeadershipPartner with Engineering, Facilities, Operations, Supply Chain, and QualityProvide practical, risk-based environmental guidance to influence decisionsSupport client and regulatory audits with clear, defensible practices. Training, Culture & EngagementDevelop and deliver environmental training programsPromote a strong environmental compliance culture and accountabilitySupport broader EHS initiatives and leadership engagement. Required qualifications:BS degree in Environmental Science, Environmental Engineering, Occupational Health & Safety, Industrial Hygiene, or related field required5-8 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 degreeDemonstrated ownership of environmental programs, permits, and regulatory interactionsStrong knowledge of RCRA, Clean Air Act, and Clean Water ActExperience with ISO 14001 or similar management systemsAbility to operate both strategically and hands-on in a complex environmentStrong regulatory interpretation and application skillsAbility to lead audits and engage with regulatorsRisk-based decision-making and problem-solvingStrong project management and organizational skillsEffective communication and influence across all levelsISO 14001 Lead Auditor certificationExperience with EHS/ESG systems (e.g., VelocityEHS)Multi-site or global operations experienceZero significant environmental compliance violationsSuccessful regulatory inspections and audit outcomesISO 14001 audit readiness and performanceReduction in environmental incidents and risksTimely and accurate environmental reportingProgress against sustainability and ESG targetsClosure and effectiveness of environmental CAPAs In return, you’ll be eligible for [1]: Day One BenefitsMedical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life InsuranceSpouse Life InsuranceChild Life Insurance401(k) Retirement Savings Plan with Company MatchTime Off ProgramPaid HolidaysPaid Time OffPaid Parental Leave and moreAdoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service ProgramEmployee Ownership PlanAdditional BenefitsShort and Long-Term Disability InsuranceVoluntary Insurance BenefitsVision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and moreOnsite Campus AmenitiesWorkout FacilityCafeteriaCredit Union[1] Current benefit offerings are in effect through 12/31/26DisclaimerThis job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.Equal Employment OpportunitySimtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Data PrivacyTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/