Manager - Engineering

Catalent Pharma Solutions•Madison, WI

20h•Onsite

About The Position

Manager – Engineering Position Summary: Work Schedule: M-F 8am-5pm 100% on-site 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!
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference.
personal initiative.
dynamic pace.
meaningful work.