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 role
We 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 responsibilities:

• Execute the EHS&S (Environmental, Health, Safety, & Sustainability) Management System elements
• Manage the administration and implementation of EHS&S policies, programs, and safety standard work
• Ensure compliance with EHS&S regulations and Simtra BPS requirements by following emerging EHS&S regulations and issues
• Proactively identify potential EHS&S hazards through risk assessments, Gemba walks, inspections, and drive timely corrective actions
• Provide regulatory guidance and administration support on all EHS &S regulations
• Provide management assistance in maintaining and setting goals and targets for all EHS&S programs
• Develops 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 techniques
• Aids with pollution prevention and waste minimization activities
• Aids in the development of EHS&S service contracts
• Perform and/or assist in IH monitoring
• Interact with regulatory agencies, as applicable
• Provide specialized training to Simtra BPS employees
• Prepare and/or assist with composing agency (e.g., EPA, IDEM, IDHS, OSHA), corporate and divisional reports
• Accomplish 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 procedures
• Assist with workers' compensation program including claims monitoring and administration, report generation, and communication with employees, managers, insurance carriers, medical staff for litigated/non-litigated claims

Required qualifications:

• BS in Environmental, Safety, Engineering, or related field
• 7+ years experience in pharmaceutical manufacturing, or regulated industry
• Professional certifications (e.g. CSP, CIH, etc.) preferred
• Experience with common pharmaceutical industrial hygiene practices (e.g. hierarchy of controls, occupational exposure banding assessments, surrogate monitoring techniques, etc.) preferred
• Experience of pharmaceutical manufacturing operations, equipment, and processes
• Experience with articulating information during regulatory and/or client inspections
• Srong knowledge of OSHA, EPA, and environmental permitting requirements
• Experience in EHS program development, training delivery, and regulatory inspections, including creating short- and long-term strategic plans
• Ability to influence and coach leaders and employees at all organizational levels
• Ability to pass a hearing and vision test
• Experience collecting and analyzing data and information to determine paths for potential root causes and process improvement
• Excellent written and oral communication skills
• Advanced proficiency in Microsoft Office Suite

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required
• Climbing, ascending, or descending ladders, stairs, scaffolding, ramps, etc.
• Stooping, bending body downward and forward by spine at the waist
• Ability 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 Benefits
  
  
  
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    
    
    
    • Spouse Life Insurance
    • Child Life Insurance
    
    
    
    
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    
    
    
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
    
    
    
    
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  
  
  
  
• Additional Benefits
  
  
  
  • Voluntary Insurance Benefits
    
    
    
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
    
    
    
    
  • Onsite Campus Amenities
    
    
    
    • Workout Facility
    • Cafeteria
    • Credit Union
    
    
    
    
  
  
  
  

[1] Current benefit offerings are in effect through 12/31/25

Disclaimer

This 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 Opportunity

Simtra 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.

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