Catalent Pharma Solutions

Biologics

Manager-Engineering

Madison, Wisconsin, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“Manager - Engineering at Catalent Pharma Solutions. Skills: Equipment lifecycle management, CapEx project management, Leadership. Oversight for equipment onboarding, retirement, introduction of new technology, and CapEx project management. Drafting or editing standard operating procedures (SOPs) for equipment operation, maintenance, and calibration”

Industry & Context.

Biologics
Problems you'll solve

Troubleshooting

Eligibility Requirements

100% on-site

What They're Looking For.

Must Have

Technical or associate degree in engineering or related scientific field with a minimum of 10+ years related work experience, Bachelor’s degree in engineering or related scientific field with a minimum of 6+ years related work experience, 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

Nice to Have

Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.

What You'll Do.

Oversight for equipment onboarding

introduction of new technology

and CapEx project management

Drafting or editing standard operating procedures (SOPs) for equipment operation

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

How You'll Work.

Team & Collaboration

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

Process & Methodology

CapEx project management, Project and team management

Full Job Description

**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. **The Role:** * 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

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