Engineer - Equipment 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 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 Equipment Engineering candidate will support Engineering activities by assisting in troubleshooting mechanical problems, identifying improvements in utilities to minimize interruptions (down time) and reduce energy usage/cost, and supporting new and ongoing projects. This position will further assist in the management and planning of project budgets and schedules and provide contractor oversight. The candidate will interact with Operations, Supply Chain, Process Development, Validation, Procurement, Manufacturing Science and Technology (MS&T) and Quality.
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.
The Role
Support the utility systems facility, including HVAC systems, process utilities, and bio-containment systems
Support selection and installation of manufacturing equipment
Equipment Lifecycle management - onboarding new technologies, Preventive Maintenance schedules, CMMS tracking, spare parts, retirement and decommissioning
Assess current and future state of site utility system capacity and utilization for improvement and maturity projects
Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements
Draft SOPs for building operation, maintenance, and calibration and author deviation investigations and change control processes.
Provide engineering guidance and execution on facilities and equipment projects. Guide the specification and selection of manufacturing/utility equipment to support site facility/ process needs
Perform hands-on activities as needed to help troubleshoot facility problems and support facility staff
Drive continuity and development of standards in FAC/EQP Engineering to ensure smooth and effective communication flow between internal resources and customers, operational efficiency, and equipment and personnel safety
Create and maintain all aspects of equipment and facility design files and maintain facility compliance in accordance with the site quality management system
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)
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
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
Problem-solving (Lean Six Sigma) and change management methodologies consistent with a culture of continuous improvement is 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 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 ******** . 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 ******** for us to investigate with local authorities.
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