Engineer - Engineering

Catalent • Madison, WI

9d • Onsite

About The Position

Catalent Biologics is seeking an Engineer to join their Equipment Engineering group in Madison, WI. This role involves equipment lifecycle management, including design, modifications, troubleshooting, training, and continuous improvement. The group also manages the capital expenditure (CapEx) process. The position offers an opportunity to work on products for various critical health conditions and to grow within a fast-paced, expanding business backed by a global company.

Requirements

• 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)

Nice To Haves

• Previous experience leading cross-department facility and/or site improvement projects, a plus

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level