Manager - Engineering

Catalent Pharma Solutions; United States; On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

PTO + holidays

401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent Biologics in Madison, WI is hiring a Manager - Engineering to oversee equipment lifecycle, CapEx, validation, and change control for a fast-growing biomanufacturing environment.

You will lead an engineering team, coordinate with internal and external resources, draft SOPs, and ensure on-time delivery of reliability and performance improvements, with opportunities for career growth within Catalent's globally integrated network.

Qualifications

• Minimum 10+ years related work experience with technical leadership in engineering/automation.
• Experience drafting SOPs, URS, HLRA, and change controls for new technology.
• Leadership experience in Catalent programs or similar accepted.

Responsibilities

• Provide guidance for equipment onboarding, retirement, and CapEx project management.
• Draft or edit SOPs for equipment operation, maintenance, and calibration.
• Develop and maintain team performance tracking systems.
• Coordinate installation, life-cycle activities, and contractor oversight.
• Manage validation documents (SIA, URS, Purchase Specs, HLRA) and change controls.
• Lead training development for new technology.

Skills

Leadership

Project management

SOP drafting

CapEx management

Equipment validation

Education

Technical or associate degree in engineering or related field

Bachelor’s degree in engineering or related field

Master’s degree in engineering or related field

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.

Role

• Provides guidance and 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
• 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

Candidate

• 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
• 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

Why you should join Catalent

• 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

Benefits

• 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. Visit Catalent Careers to explore career opportunities.

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

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time‑tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.