Engineer - Automation

Catalent - Madison, WI

Full-time - Entry Level

Madison, WI

10,001+ employees

Chemical Manufacturing

About the position

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. 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 Automation Engineering Department is responsible for all computer systems, network, and automation, of direct and indirect equipment to the manufacturing process, laboratory, and facility systems. Project management for information & operational technology (IOT) initiatives. Engineers with the department are responsible for working on a wide variety of systems and projects both within their respective discipline and overlapping with other engineers giving exposure to continued learning. This is a full-time on-site position, Monday - Friday 8am-4:30pm. 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.

Responsibilities

• Administration of production skids and equipment utilizing networked or standalone control systems.
• Monitor, maintain, and repair existing production and laboratory control and monitoring systems (programmable logic controllers, various software control systems, etc.).
• SQL, Historian or similar database administration including configuration, design, queries, and logical extraction for reporting.
• Set-up designated users who will manage and create reporting structure.
• Support validation and qualification of computerized or automated systems.
• Author, review and approve change controls to computerized production and laboratory systems through the change control program to assess impact on validated systems.
• Work with process, equipment and facility engineers to ensure equipment is running in automated fashion.
• Lead projects for improvement/site maturity of automation to reduce user manual interaction and add consistency to production and product safety.
• Author and/or participate in investigations related to deviations and deviation management caused by automated system failures.
• Assist in audit observations and corrective actions as it pertains to automation/computerized systems.
• Author system administrative and operation procedures to ensure all aspects of system management contains defined management steps and sufficient detail for consistent implementation, training, or operation.
• Contribute to the site digitization transformation (IOT/Automation 4.0) roadmap.
• Networking, integration and communication, data transformation and mapping, and stakeholder interaction.
• Complete tasks assigned by lead or as part of project work with minimal oversight, meeting tasks intent and schedule.

Requirements

• Minimum B.S. degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field with 3+ years' facilities operation/automation engineering experience in a cGMP environment (preferably biopharmaceutical) OR M.S. degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field with 1+ years' facilities operation/automation engineering experience in a cGMP environment (preferably biopharmaceutical).
• Previous experience leading cross-department facility and/or site improvement projects, a plus.
• Problem-solving (Lean Six Sigma) and change management methodologies consistent with a culture of continuous improvement is preferred.
• Must be proficient in operation and troubleshooting of a wide variety of instrumentation and data systems.
• Ability to provide ideas, introduce new technology, and drive process improvements.
• Work with other groups to develop, qualify, and transfer methods accordingly.
• Ability to cross-train on techniques across multiple groups.
• Experience writing, editing, and reviewing Standard Operating Procedures preferred.

Nice-to-haves

• Experience with IOT and Automation 4.0 technologies.
• Familiarity with regulatory compliance in a biopharmaceutical environment.

Benefits

• 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.