Manager - Engineering

Catalent Pharma Solutions; Madison (AL); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

PTO 152 hours

8 paid holidays

401K match

Health benefits from day one

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Madison, WI is hiring a Manager - Engineering to lead the Equipment Engineering group responsible for lifecycle management, CAPEX projects, and equipment qualification from URS to release.

The role requires a technical or engineering background with years of leadership experience and a track record of delivering improvements in complex manufacturing environments; on-site work is required.

Qualifications

• 10+ years of engineering/automation work experience (leadership preferred).
• Bachelor’s degree in engineering or related field with 6+ years experience.
• Master’s degree with 3+ years experience.
• Minimum 2 years of leadership experience with engineering/automation personnel.

Responsibilities

• Provide guidance and oversight for equipment onboarding and CapEx project management.
• Draft or edit SOPs for equipment operation, maintenance, and calibration.
• Develop and maintain team performance tracking systems.
• Schedule and coordinate equipment lifecycle activities with internal/external resources.
• Oversee equipment contractors and validation documents (URS, SIA, HLRA).
• Manage drafting and execution of change controls and change control action for new technology.
• Develop and execute training plans for new technology.
• All other duties as assigned.

Skills

Leadership experience

Project management

Education

Technical or associate degree in engineering or related scientific field

Bachelor’s degree in engineering or related scientific field

Master’s degree in engineering or related scientific 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.

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
• 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
• 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.

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 [e-mail]. 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.