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Engineer - Facilities Engineering - Madison Wisconsin
Company: Disability Solutions Location: Madison, Wisconsin
Posted On: 05/03/2024
Engineer - Facilities EngineeringSummaryCatalent 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 Engineering Department is responsible for all facilities, automation, equipment and process operations of direct and indirect equipment to the manufacturing process, and project management for any CAPEX, Continuous Improvement and Ste Strategy projects. This department manages facilities planning, construction, and renovation, including primary contact and management of architects, design engineers, contractors, and subcontractors. The Engineering Department is also responsible for managing the facility in a manner that assures uninterrupted cGMP compliance in existing manufacturing areas, as well as the research and process development areas.The Engineer will support ongoing Facilities 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.This person will work on complex facility-related problems requiring in-depth data analysis to determine appropriate action. The Engineer is expected to have extensive ongoing communication with employees and cross-functional group managers/departments on facility-related issues.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 multi-use facility, including HVAC systems, process utilities, and bio-containment systems
- Assess the current and future state of site utility system capacity and utilization and support selection and installation of manufacturing equipment.
- 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 identify improvements and efficiencies of facility preventative maintenance.
- Provide engineering guidance and execution on facilities and equipment projects
- Perform hands-on activities as needed to help troubleshoot facility problems and support facility staff.
- Develop standard processes to evaluate future capital projects.
- Create and maintain all aspects of equipment and facility design files. Maintain facility compliance in accordance with the site quality management system
- Author deviation investigation and change control process
- Other duties as assigned.The Candidate
- Minimum B.S. degree in Industrial, Electrical, Mechanical, Chemical, or Civil Engineering
- Minimum 3 years' facilities operation/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 establishing a culture of continuous improvement are preferred.
- Candidate needs to be highly motivated, have excellent written and verbal communication skills, and critical thinking and problem-solving skills. --
- Ability to use Excel, Word, and other office systems.
- Ability to cross-train on techniques across multiple groups and is proficient in the operation and troubleshooting of a wide variety of instrumentation and data systems.
- Understanding and adherence to applicable regulatory authority and guidelinesPhysical 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:
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