Manager - Engineering

Catalent • Madison, WI

3d • Onsite

About The Position

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI,and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.
Catalent Pharma Solutions in Madison, WI is hiring a Manager - Engineering. 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 (CapEx) process.

Requirements

• Technical or associate degree in engineering or related scientific field with a minimum of 10+ years related work experience OR
• Bachelor’s degree in engineering or related scientific field with a minimum of 6+ years related work experience OR
• Master’s degree in engineering or related scientific field with a minimum of 3+ year related work experience
• Minimum of 2 years of Leadership experience with engineering/automation personnel or project and team management

Responsibilities

• Provides guidance and oversight for equipment onboarding, retirement, introduction of new technology, and CapEx project management including but not limited to:
• Drafting or editing standard operating procedures (SOPs) for equipment operation, maintenance, and calibration
• Develop, implement, and maintain team performance tracking systems
• Schedule and coordination of equipment life-cycle activities with internal and external resources
• Schedule and coordination of installation and set-up activities with internal and external resources
• Oversees equipment contractors
• Manage drafting and completion of validation and onboarding documents including but not limited to System Impact Assessments (SIA), User Requirement Specifications (URS), and Purchase Specifications, and High-Level Risk Assessments (HLRA)
• Manage drafting and execution of change controls and change control action for new technology
• Development and execution of training plans for new technology
• All 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 - Let us help you finish your degree or start a new degree!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees