Associate Engineer - Facilities, Equipment
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 Associate Equipment Engineering candidate will work on the Equipment team within the Engineering department. The candidate will interact with Operations, Supply Chain, Process Development, Validation, Procurement, Manufacturing Science and Technology (MS&T) and Quality to perform the following responsibilities:
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
- Perform hands-on activities to install, onboard, help troubleshoot equipment failures and retire equipment including but not limited to:
- Perform asset induction requests and asset retirement requests
- Scheduling and coordination of installation, calibration and set-up activities with internal and external personnel
- Drafting validation and onboarding documents including but not limited to System Impact Assessments (SIA), User Requirement Specifications (URS), and Purchase Specifications, and High-Level Risk Assessments (HLRA)
- Support training development plan for new technology
- Edit and modify Standard Operating Procedures (SOPs) for equipment operation, maintenance, and calibration
- Identify improvements and efficiencies of equipment life cycle / reliability engineering and support process improvement implementation
- Completion of change control tasks related to equipment such as writing or updating procedures for use and maintenance, identifying spare parts, and new technology introduction tasks
- Partner with equipment technicians to ensure proper implementation of preventative and repair maintenance activities
- Other duties as assigned.
The Candidate
- Bachelor's degree in Engineering or related scientific field with applicable knowledge OR
- Technical or Associate degree in a technology/computer based or related scientific field with 1-2 years related work experience OR
- Equivalent combination of training, education, and experience
- Related work experience or previous intern/co-op program experience preferred
- Ability to formulate comprehensive materials such as authoritative reports and/or to create/deliver informal presentations.
- Ability to cross-train on techniques across multiple groups.
- Ability to provide ideas, introduce new technology, and drive process improvements with support from team and supervisor. Work with other groups to develop, qualify and transfer methods accordingly.
- Problem solving (Lean Six Sigma) and change management methodologies consistent with establishing 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 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.
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