Engineering Support Professional
5 days ago
We are a diverse, inclusive culture that values innovation and continually improving processes to remain competitive.
Our team is committed to preserving and bettering lives through our work in the pharmaceutical industry.
About the RoleThe Facility Maintenance Engineer will be responsible for maintaining and remodeling existing facilities and utilities, coordinating capital projects, and providing engineering support to the site maintenance department.
This position will have a strong focus on continuous improvement of facility and utility equipment achieved through project identification and execution.
Key Responsibilities- Maintenance Management: Lead the life cycle management and maintenance of critical systems, including HVAC, electrical, plumbing, cleanrooms, and mechanical spaces to ensure they are functioning efficiently, safely, and in compliance with pharmaceutical standards.
- Project Management: Plan and execute 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: Ensure 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: Investigate and resolve issues resulting from utility, facility, and/or equipment malfunctions.
- Vendor Management: Select and manage contractors and service providers for maintenance, security, cleaning, and other services, ensuring they meet the site requirements.
- Emergency Planning: Develop, implement, and execute emergency plans and procedures, including evacuation plans, to respond to emergencies such as weather events, utility disruptions, chemical spills, etc.
- Space Management: Optimize 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: Assess the design and operation of building systems to improve efficiency, reliability, and sustainability.
- Regulatory Compliance: Ensure 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: Lead 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.
Bachelor's Degree in Mechanical, Electrical, or Chemical Engineering with a minimum of two+ years of relevant 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 is 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 is required.
Proficient at relevant software, including MS Office, MS Project, AutoCAD, Inventor, CAD, Trackwise, Documentum, highly preferred.
Knowledge regarding design control documentation, risk management, and processes, such as FMEA, Design Verification, and URS, is a plus.
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