Engineer - Engineering

Engineer Position Summary

• Work Schedule: M-F 8am-5pm
• 100% on-site

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics invests in people and capabilities.

Catalent Pharma Solutions in Madison, WI is hiring an Engineer.

The Equipment Engineering group has oversight of equipment lifecycle management inclusive of equipment design (URS through qualification support and release), equipment updates (design modifications via change management), and general equipment support through troubleshooting, training, and continuous improvement. This function also maintains ownership of the capital expenditure (Cap Ex) process.

• Support the utility systems facility, including HVAC systems, process utilities, and bio-containment systems
• Support selection and installation of manufacturing equipment
• Equipment Lifecycle management - onboarding new technologies, Preventive Maintenance schedules, CMMS tracking, spare parts, retirement and decommissioning
• Assess current and future state of site utility system capacity and utilization for improvement and maturity projects
• Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements
• Draft SOPs for building operation, maintenance, and calibration
• Provide engineering guidance and execution on facilities and equipment projects
• Perform hands‑on activities as needed to help troubleshoot facility problems and support facility staff
• Drive continuity and development of standards in FAC/EQP Engineering to ensure smooth and effective communication flow between internal resources and customers, operational efficiency, and equipment and personnel safety
• Create and maintain all aspects of equipment and facility design files
• Maintain facility compliance in accordance with the site quality management system
• Guide the specification and selection of manufacturing/utility equipment to support site facility/process needs
• Author deviation investigation and change control process
• Other duties as assigned

• Minimum B.S. degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field with 3+ years' facilities operation/automation engineering experience in a cGMP environment (preferably biopharmaceutical) OR
• M.S. degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field with 1+ years' facilities operation/automation engineering experience in a cGMP environment (preferably biopharmaceutical)
• Previous experience leading cross-department facility and/or site improvement projects, a plus

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement – Let us help you finish your degree or start a new degree

Catalent is an Equal Opportunity Employer, including disability and veterans.