Description:
This is a full-time, salary role. This is onsite. This position is a 1st Shift role with flexibility on the weekends.
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:
- Maintenance Management: Leading the life cycle management and maintenance of critical systems (HVAC, electrical, plumbing, cleanrooms, mechanical spaces) to ensure they are functioning efficiently, safely, and in compliance with pharmaceutical standards
- Project Management: Planning and executing projects related to the expansion, renovation, or upgrades of pharmaceutical manufacturing facilities, including budgeting, scheduling, and ensuring compliance with Good Manufacturing Practices (GMP)
- Safety Compliance: Ensuring that the facility complies with all relevant health, safety, and environmental regulations and standards, including those specific to the handling and manufacturing of pharmaceuticals
- Quality Compliance: Leading investigation and resolution of issues resulting from utility, facility, and/or equipment malfunctions
- Vendor Management: Selecting and managing contractors and service providers for maintenance, security, cleaning, and other services, ensuring they meet the site requirements
- Emergency Planning: Developing, implementing, and executing emergency plans and procedures, including evacuation plans, to respond to emergencies, such as weather events, utility disruptions, chemical spills, etc
- Space Management: Optimizing the use of space within the facility, including planning for future space requirements, cleanroom standards, and segregation of different manufacturing operations
- Building Systems Design and Analysis: Assessing the design and operation of building systems to improve efficiency, reliability, and sustainability
- Regulatory Compliance: Ensuring that the facility and its operations comply with all local, state, federal, and international regulations and codes relevant to pharmaceutical manufacturing, including GMP and FDA regulations
- Sustainability Initiatives: Leading efforts to make the facility more sustainable, such as implementing recycling programs, reducing energy consumption and cost, water conservation measures, and green building practices, while ensuring these initiatives do not compromise product quality or safety
- All other duties as assigned
The Candidate:
- Bachelor’s Degree in Mechanical, Electrical or Chemical Engineering with a minimum of two+ years of relevant of experience in development, manufacturing or packaging for clinical/commercial drug products or combination products in a cGMP-controlled environment or regulated industry is required
- Ability to troubleshoot simple to complex process and equipment problems using a structured problem-solving approach is required
- Knowledge of change control and validation required including experience with equipment FAT, Commissioning, IQ, OQ, PQ, and development of qualification protocols/reports for packaging and shipping activities highly desired
- Demonstrated ability to plan and independently implement multiple projects with high attention to detail
- Proficient at relevant software including MS Office, MS Project, AutoCAD Inventor, CAD, Track wise, Documentum highly preferred
- Knowledge regarding design control, documentation, risk management and processes such as FMEA, Design Verification, and URS is a plus
- Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer is required
- Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds