EHS 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, Health & Safety (EHS) Manager is responsible for ensuring compliance with all federal, state, and local environmental, health and safety regulations; ISO 14001, ISO 45001 and Company Policies. This position develops and implements programs, strategies, policies, training, and procedures to reduce/eliminate risks; sustain a management system; and to drive a culture of continuous improvement. This position is also responsible for maintaining an industrial hygiene program that includes monitoring and sampling. This candidate reports to the Associate Director of EHS&S and is 100% onsite at the Bloomington, Indiana facility.

The responsibilities:

* Monitor and assess worker exposure to active pharmaceutical ingredients (APIs), solvents, and other hazardous chemicals
* Oversee air sampling, surface contamination testing, and cleanroom environmental monitoring
* Ensure compliance with Good Manufacturing Practices (GMP) and ISO cleanroom standards
* Ensure compliance with OSHA, NIOSH, EPA and FDA and prepare for applicable regulatory inspections and audits
* Develop and maintain programs for respiratory protection, hearing conservation, chemical hygiene and potent compound handling and decontamination protocols and PPE requirements
* Develop and implement programs and procedures to assure site compliance with applicable federal, state, and local environmental, industrial hygiene and safety regulations
* Assist operations in planning for compliance of new and modified processes
* Assist regulatory agencies in the preparation of permits and application renewal in compliance with applicable regulations
* Manage and provide technical guidance to the EHS staff
* Conduct and manage risk assessments to reduce job and facility risks
* In collaboration with senior management, develop and implement site policies and procedures that drive improvement in the facility occupational, health and safety performance
* Develop and implement safety and occupational health training programs for current employees, newly hired personnel, and contractors
* Provide support for regulatory and company performance reporting according to environmental permits, RCRA, community right-to-know and company policy.
* Oversee contractor safety programs
* Participate in near miss, incident, and accident investigation to identify and correct the root cause using Lean techniques
* Lead the identification of root causes of regulatory or company non-conformances and track corrective and preventive actions for timely completion
* Manage changes at the facility that have EHS impact by providing technical information on new or changed projects, equipment, processes, and procedures
* Stay current on any changes in the regulations and sharing of best practices
* Coach employees, supervisors, and local leadership to improve the technical skill base in environmental, health and safety related areas
* Formulate and implement local environmental, health, safety and security strategies and procedures to be followed by local personnel, who are designed to identify and resolve risks; are in compliance with local, state and federal safety, health and environmental laws and regulations; and are consistent with Simtra global policies and procedures
* Provide technical guidance to manufacturing, engineering and quality control groups through participation in safety committees

Desirable qualifications:
* Bachelor's Degree required in Environmental, Safety or related field (Master's degree preferred)
* 7+ years related experience, which includes leadership experience through direct supervision or indirect leadership roles (project management, leading teams, mentoring)
* Knowledgeable in EPA, OSHA, NIOSH, FDA and DOT regulations
* Preferred certification in the environmental or safety field (i.e., CHMM, CSP, or CIH)
* Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

Physical / Safety Requirements:
* Duties may require overtime work, including nights and weekends
* Must be able to wear a respirator and emergency response equipment
* Position may require sitting or standing for long periods of time

n 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 12/31/24

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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