ENGINEER - AUTOMATION

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.
• 5,000 Sign-On Bonus Available)
• 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 :
• 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. 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.
• Other duties as assigned.
• The Candidate :
• 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)
• 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
• Physical Requirements :
• 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 10 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 Conditioned controlled.
• Ability to operate within a clean room environment as needed.
• 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.

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