Sr. EHS Specialist

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 roleWe are looking for a Sr. Environmental, Health, & Safety (EHS) Specialist to develop, implement and administrate applicable environmental, health, safety (EHS) and Industrial Hygiene (IH) policies and programs. This person is responsible for compliance with all federal, state, and local EHS regulations. They will provide technical EHS support to operations, quality, engineering, facilities, maintenance, and supply chain functions, as applicable. This position is 100% onsite at the Bloomington, Indiana facility.The ResponsibilitiesExecute the EHS&S (Environmental, Health, Safety, & Sustainability) Management System elementsManage the administration and implementation of EHS&S policies, programs, and safety standard workEnsure compliance with EHS&S regulations and Simtra BPS requirements by following emerging EHS&S regulations and issuesProactively identify potential EHS&S hazards through risk assessments, Gemba walks, inspections, and drive timely corrective actionsProvide regulatory guidance and administration support on all EHS &S regulationsProvide management assistance in maintaining and setting goals and targets for all EHS&S programsDevelops relationships with other functions (i.e., HR, operations, quality, engineering & supply chain) to ensure EHS&S aspects are considered at the beginning of new/changing operations and drives improvement existing EHS&S methods and techniquesAids with pollution prevention and waste minimization activitiesAids in the development of EHS&S service contractsPerform and/or assist in IH monitoringInteract with regulatory agencies, as applicableProvide specialized training to Simtra BPS employeesPrepare and/or assist with composing agency (e.g., EPA, IDEM, IDHS, OSHA), corporate and divisional reportsAccomplish EHS&S performance related to Key Performance Indicators (KPIs) by communicating job expectations, planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees and by initiating, coordinating, and enforcing systems, policies, and proceduresAssist with workers' compensation program including claims monitoring and administration, report generation, and communication with employees, managers, insurance carriers, medical staff for litigated/non-litigated claimsRequired QualificationsBS in Environmental, Safety, Engineering, or related field7+ years experience in pharmaceutical manufacturing, or regulated industryProfessional certifications (e.g. CSP, CIH, etc.) preferredExperience with common pharmaceutical industrial hygiene practices (e.g. hierarchy of controls, occupational exposure banding assessments, surrogate monitoring techniques, etc.) preferredExperience of pharmaceutical manufacturing operations, equipment, and processesExperience with articulating information during regulatory and/or client inspectionsSrong knowledge of OSHA, EPA, and environmental permitting requirementsExperience in EHS program development, training delivery, and regulatory inspections, including creating short- and long-term strategic plansAbility to influence and coach leaders and employees at all organizational levelsAbility to pass a hearing and vision testExperience collecting and analyzing data and information to determine paths for potential root causes and process improvementExcellent written and oral communication skillsAdvanced proficiency in Microsoft Office SuitePhysical / Safety RequirementsDuties may require overtime work, including nights and weekendsPosition requires sitting for long hours, but may also involve walking or standing for long periods of timeMust be able to lift, push, pull, and carry up to 50 lbsMust be able to lift 20 lbs overheadMust be able to wear personal protective equipment (PPE), as requiredClimbing, ascending, or descending ladders, stairs, scaffolding, ramps, etc.Stooping, bending body downward and forward by spine at the waistAbility to be exposed to adverse environmental conditions (such as extreme cold or hot conditions when evaluating storage environments)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 ProgramAdditional 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/