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 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 [1] :

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

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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