Manager - Engineering

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 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.
   

The Candidate:

• 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

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 
• 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.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Global CDMO providing drug delivery, development, and manufacturing solutions for pharma and biotech. Based in Somerset, NJ.

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