Engineer – Facilities Engineering
Catalent
- Madison, WI
- Permanent
- Full-time
- 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.
- 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 guidelines
- 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.
- 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