Operational Risk Manager Jobs in Indiana (NOW HIRING)

Bloomington, Indiana, United States

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.

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 Leadership

• 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
• Interpret evolving requirements and proactively implement changes
• Maintain and optimize environmental permits (air, water, waste) and ensure adherence to conditions
• Lead environmental compliance risk assessments and mitigation strategies

Environmental Management System (ISO 14001)

• 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
• Establish and track environmental objectives, targets, and KPIs
• Integrate EMS requirements into site operations, procedures, and culture.

Operational Risk & Chemical Management

• Lead environmental components of operational risk assessments for routine and non-routine work
• Oversee chemical management programs including SDS compliance, approvals, and inventory controls
• Partner with operations and engineering to evaluate environmental risks for new materials and processes.

Waste Management & Compliance

• Oversee hazardous and non-hazardous waste programs in compliance with RCRA and applicable regulations
• Ensure proper waste characterization, storage, labeling, and disposal
• Manage vendor relationships and ensure compliant transport and disposal
• Drive waste minimization and cost reduction initiatives.

Air, Water & Environmental Programs

• Manage air emissions programs, including permitting, reporting, and monitoring
• Oversee wastewater and stormwater programs and permit compliance
• Identify opportunities to improve environmental performance and reduce footprint
• Ensure accurate and timely environmental reporting (TRI, Tier II, emissions inventories).

Sustainability & ESG Integration

• Lead site sustainability initiatives (waste, energy, water)
• Support ESG data collection, validation, and reporting
• Align environmental strategy with broader business objectives.

Project & Change Management

• Provide environmental oversight for capital projects, expansions, and new product introductions
• Ensure environmental requirements are incorporated into design, commissioning, and change control
• Support environmental impact assessments for new processes and technologies.

Cross-Functional Leadership

• Partner with Engineering, Facilities, Operations, Supply Chain, and Quality
• Provide practical, risk-based environmental guidance to influence decisions
• Support client and regulatory audits with clear, defensible practices.

Training, Culture & Engagement

• Develop and deliver environmental training programs
• Promote a strong environmental compliance culture and accountability
• Support broader EHS initiatives and leadership engagement.

Required qualifications:

• BS degree in Environmental Science, Environmental Engineering, Occupational Health & Safety, Industrial Hygiene, or related field required
• 5-8 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 degree
• Demonstrated ownership of environmental programs, permits, and regulatory interactions
• Strong knowledge of RCRA, Clean Air Act, and Clean Water Act
• Experience with ISO 14001 or similar management systems
• Ability to operate both strategically and hands-on in a complex environment
• Strong regulatory interpretation and application skills
• Ability to lead audits and engage with regulators
• Risk-based decision-making and problem-solving
• Strong project management and organizational skills
• Effective communication and influence across all levels
• ISO 14001 Lead Auditor certification
• Experience with EHS/ESG systems (e.g., VelocityEHS)
• Multi-site or global operations experience
• Zero significant environmental compliance violations
• Successful regulatory inspections and audit outcomes
• ISO 14001 audit readiness and performance
• Reduction in environmental incidents and risks
• Timely and accurate environmental reporting
• Progress against sustainability and ESG targets
• Closure and effectiveness of environmental CAPAs

In return, you'll be eligible for:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life 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
• Employee Ownership Plan
• Additional Benefits
• Short and Long-Term Disability Insurance
• 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 12/31/26

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.

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender,