Senior Facilities Engineer — Pharma Ops & Compliance

Ifmadison; Verona (WI); On-site; USD 90,000 - 150,000; Full time

Job summary

Ani Pharmaceuticals in Verona, WI seeks a Sr. Facilities Engineer to lead facility and process equipment projects in a cGMP environment. You will implement CI tools, manage maintenance, and coordinate EHS programs while ensuring compliance with FDA/OSHA/WDNR requirements.

The role collaborates across Management, Engineering, Maintenance, and Operations, mentoring junior staff and driving long-term improvements for reliability and regulatory readiness.

Qualifications

• BS or MS in Pharmaceutical Sciences, Engineering, or a related discipline.
• Minimum 5 years of experience in facilities or engineering within a pharmaceutical manufacturing environment.
• Demonstrated leadership in equipment installation, qualification, and maintenance projects.
• Strong knowledge of regulatory compliance including FDA, OSHA, and WDNR.
• Experience with pharmaceutical processing equipment and utilities preferred.

Responsibilities

• Lead the purchase, installation, and qualification of plant and process equipment.
• Supervise the organization and maintenance of engineering documentation including drawings, schematics, and manuals.
• Develop and implement maintenance and calibration procedures for equipment and utilities.
• Support IQ/OQ/PQ and process validations.
• Collaborate with Operations and Compliance teams to ensure adherence to federal, state, and local regulations including FDA, OSHA, and WDNR.
• Conduct and lead routine inspections of laboratories, manufacturing suites, and warehouse areas to ensure compliance with hazardous waste and safety regulations.
• Mentor junior engineers and technicians, providing technical guidance and support.
• Contribute to strategic planning for facility upgrades, process improvements, and long-term engineering initiatives.
• Troubleshoot equipment issues; participate in investigations as needed.
• Coordinate and oversee EHS programs and environmental permitting.

Skills

Leadership

Regulatory compliance

Project management

Cross-functional collaboration

Continuous Improvement

Education

BS/MS in Pharmaceutical Sciences or Engineering

Job description

Ani Pharmaceuticals in Verona, WI seeks a Sr. Facilities Engineer to lead facility and process equipment projects in a cGMP environment. You will implement CI tools, manage maintenance, and coordinate EHS programs while ensuring compliance with FDA/OSHA/WDNR requirements.

The role collaborates across Management, Engineering, Maintenance, and Operations, mentoring junior staff and driving long-term improvements for reliability and regulatory readiness.