Senior Supervisor - Engineering

Summary

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.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

The Engineering department’s primary function is to serve as an agile technical services team to support process, consumables, automation, and troubleshooting equipment management. The Engineering organization supports the Madison facility as well as Catalent Biologic’s network through CAPEX management, automation and controls, on-the-floor or on-call technical coverage, and continuous improvement. The team is broken down into three key subgroups:

• Engineering, Process Engineering

• Engineering, Equipment Engineering

• Engineering, Automation 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.

This is a full-time on-site position, Monday – Friday 8:00am-5:00pm.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

• Supervise Equipment personnel by assigning tasks per knowledge assessment of team, and priorities, providing guidance, and serving as a resource for technical and administrative issues.

• Onboards, trains, motivates and leads Equipment personnel with an emphasis on team and individual development.

• 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

• 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)

• Drafting and execution of change controls and change control action for new technology

• Development and execution of training plans for new technology

• Lead investigator for deviations, including drafting impact assessments, risk analysis, performing root cause analyses, and development and execution of corrective actions for equipment-related deviations.

• Serves as an Equipment contact and subject matter expert (SME) for equipment lifecycle and CapEx processes.

• Implements improvements to established systems, processes, procedures, etc. to support Equipment management systems with minimal oversight.

• Takes responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly.

• Works with, coaches, and supports direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development.

• Other duties as assigned.

The Candidate

• Technical or associate degree in engineering or related scientific field with a minimum of 10+ years of related work experience OR

• Bachelor’s degree in engineering or related scientific field with a minimum of 6+ years of related work experience OR

• Master’s degree in engineering or related scientific field with a minimum of 3+ years of related work experience

• Minimum of 3 years’ experience in a people leadership role.

• Project and Team Management experience required.

• 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.

• Excellent written and verbal communication skills with internal and external customers.

• Ability to communicate complex technical information to non-technical audiences.

• Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.

• Understanding of proposal and project scope as it relates to pricing, resources management and the impact on business.

Safety and Environmental Requirements:

• May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.

• Occasional stooping, kneeling, crouching, bending, carrying, grasping.

• Frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 50 pounds.

• Must comply with EHS responsibilities for the position.

• Working conditions will be heating ventilation and air condition controlled.

• Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 hours of paid time off annually + 8 paid holidays

• Competitive salary with yearly bonus potential

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .