Principal Automation Engineer 

Position Description

Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers’ growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.

The Principal Automation Engineer, will support ongoing activities by assisting in troubleshooting problems, identifying improvements to minimize interruptions (down time) and supporting new and ongoing projects. This includes system administration, system design production support, laboratory equipment, process improvement, GAMP/Part 11 compliance, preventative maintenance, project support and operational network design.

This position will assist in identifying, tracking, forecasting, and implementing capital expenditure projects by working with site leadership and departmental end users to identify the automation road map for the site. Establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on site needs.

This is a fulltime role working Days; Monday – Friday

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:

• Administer the sites process control systems, digital control system, and equipment specific systems.
• Monitor, maintain, and repair existing production and laboratory control and monitoring systems (programmable logic controllers (PLC type systems), software, etc.).
• Server management, disaster recovery, system backups, data management, secure analytical data results.
• SQL, Historian, or similar database administration. Configuration, Design, Queries, and logistical extraction for reporting. Set up designated users who will manage and create reporting structure.
• Identify and implement improvement opportunities for established production systems
• Work with process engineers or facility technicians to ensure equipment is running in an automated fashion, making improvements to automated unit operations to minimize user interaction and add consistency to production/product safety.
• Act as primary Subject Matter Expert (SME) for CSV and alignment with corporate IT policies
• Author and/or participate in investigations related to deviations and deviation management caused by automated system failures.
• Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to automation system validation.
• Author system administrative procedures to ensure all aspects of system management contains defined management steps and sufficient detail to ensure consistent implementation.
• System Back up, Access Reviews, Audit Trail Reviews, HMI/PLC Health, Server, or computer updates
• Monitor, maintain, and repair existing production and laboratory control and monitoring systems (PLC, sub-networks, software, etc.).
• Act as project manager or subject matter expert on all projects that touch a network, computer, or controller either as support for large project or in entirety for smaller projects.
• Create and support site Automation Vision / Roadmap to keep Catalent competitive with peers to be Partner of Choice for external customer business.
• Mentor and Train co-workers on administration and access ensuring all identified systems have multiple administrators with at least the minimum required knowledge to support operations and troubleshooting.
• Limited after-hours support will be needed for special projects and downtime avoidance.
• Actively support sister site sharing and benchmarking to learn and leverage knowledge from site to site.
• Continue Automation / Digitization Roadmap for site Vision and Strategy of Automation Projects and Improvements.
• Other during as assigned.

The Candidate:

• Minimum Bachelor's degree in Engineering or related scientific field with applicable knowledge.
• Minimum 8+ years’ experience with facility network, architecture, and integration in a cGMP environment (preferably biopharmaceutical) implementing GAMP/Part 11 compliant systems.
• Project management experience, preferred.
• Ability to use Excel, Word, and other office systems.
• Ability to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver formal and informal presentations.
• Ability to cross-train on techniques across multiple groups and skill levels.
• Ability to independently interpret data, analyze trends, and provide insight into potential issues and subsequent solutions.
• Ability to complete investigation, deviation, and change control forms independently.
• Proficient in operation and troubleshooting of a wide variety of instrumentation and data systems (PCS, DeltaV, Allen/Bradley, PLC for example).
• Ability to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify and transfer methods accordingly.
• Understanding and adherence to applicable regulatory authority and guidelines.

Why you should join Catalent:

• Fast tracked career growth, with annual performance review and feedback process
• Competitive base salary with other compensation incentives including yearly incentive plan
• Medical, Dental, Vision, and 401K are all offered on day one of employment
• 19 days of Paid Time Off (152 hours PTO) + 8 paid holidays
• Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention!
• Defined career path and annual performance review and feedback process

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 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.