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Senior Engineer, Engineering - Facilities & Maintenance - Bloomington Indiana
Company: Disability Solutions Location: Bloomington, Indiana
Posted On: 05/08/2024
Senior Engineer, Facilities & MaintenanceCatalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--Process Engineering focuses on developing processes to minimize risks to the product. The Engineering department is responsible for supporting CGMP operations through process engineering, facilities and utilities engineering, calibration, process improvement and automation, packaging, capital projects, while maintaining compliance with regulatory standards.--The Senior Engineer, Facilities & Maintenance, serves as a subject matter expert supporting ongoing 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 position will assist in identifying, tracking, forecasting, and implementing capital expenditure projects by working with site leadership and departmental end users to identify the correct project parameters and utility requirements. The Engineer may establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on facility needs. 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 fulltime role working days; Monday - Friday There is a $10,000 sign on for this role.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: - Investigate and document technical problems for identified non-conformances.
- 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
- Identify improvements and efficiencies of facility preventative maintenance
- Perform hands-on activities, often partnering with the maintenance, as needed to help troubleshoot facility problems and support facility staff
- Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to automation system validation
- Collaborate significantly with cross functional groups including Validation, Quality Control, Manufacturing, Process Development, and Facilities
- Other duties as assignedThe Candidate:
- Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline, required, or 8 years of engineering experience in lieu of the degree
- PE / Registered Engineer in training, preferred
- OSHA 10 or equivalent, preferred
- 5+ years of Project Engineering relevant experience
- 2+ years in a regulated industry (Life Sciences, preferred)
- Must be able to read and understand English-written job instructions and safety requirementsWhy You Should Join Catalent
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