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Principal Engineer – Automation 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.

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.

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 and establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on site needs.

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

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 systems, 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, and 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 a reporting structure.

• Create computerized equipment configuration, set up, procedures and training, equipment and control system troubleshooting and repair. Respond and assist with troubleshooting equipment problems or connections and user access administration for both appropriate levels of security control and user.

• 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 and working with Validation, assist in drafting, reviewing, executing, and approving protocols and reports related to Automation/Computer System Validation (CSV). This includes deviation reporting during execution.

• 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

• Create and support site Automation Vision / Roadmap to keep Catalent competitive with peers to be Partner of Choice for external customer business and 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 a 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.

• Proficient in Excel, Word, and other office systems.

• Skilled in creating complex reports and delivering presentations, with the ability to cross-train across various groups.

• Capable of independently interpreting data, analyzing trends, and completing investigation, deviation, and change control forms.

• Experienced in operating and troubleshooting various instrumentation and data systems (e.g., PCS, DeltaV, Allen/Bradley, PLC).

• Ability to introduce new technologies, drive process improvements, and collaborate with teams to develop and transfer methods.

• Strong understanding and adherence to regulatory guidelines and standards.

• Requires frequent sitting, standing, walking, reading, computer use, and occasional physical activities such as lifting up to 50 pounds, with compliance to EHS responsibilities and ability to work in HVAC-controlled and clean room environments.

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.

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) .