GMP Facilities Supervisor

Who we are

The Opportunity

What You'll Be Doing

• Ensure that all facility utilities preventive maintenance is performed in accordance with cGMP guidelines maintaining departmental industry compliance in support of GMP Manufacturing, Product Development administrative and laboratory activities.
• Examines all non-emergency work orders to be completed and determines scope and best way to accomplish the work. Identifies and obtains materials required on the work order. Consults with requester, maintenance coordinator, engineers, or craftsman when necessary.
• Plans, supervises, and reviews all recurring PM (preventive maintenance) activities.
• Coordinates all PM and repair activities with manufacturing operations, purchasing, materials management, maintenance personnel and maintenance management.
• Supervise the CMMS (Blue Mountain) maintenance records for accuracy and completeness.
• Has at least 3-5 years’ experience operating Desigo CC with a thorough understanding of how these systems function.
• Experience using Microsoft Excel and Word.
• Understand Root Cause Analysis and how to write deviations.
• Supervise preventative maintenance of all GMP utilities. Utilities to include clean steam, WFI, RO/DI water, boilers, compressed gases, HVAC systems, electrical, life safety, and emergency power system (UPS).
• Planning and scheduling for shutdowns (major and minor).
• Participate in client and regulatory audits, audit responses and follow up corrective actions when required.
• Generate SOPs, deviations, and change control as required for related Facilities systems.
• Revise SOPs as required for updated systems and procedures.
• Supervise facility support contractors, including security, pest control, waste management, fire systems, and landscaping.
• Keep the Senior Manager of Facilities and Director Engineering informed of abnormal or critical situations and seek advice on matters outside the Planner's knowledge or authority.
• Maintain up to date records for all state, federal, and local licenses, and inspections.
• Order replacement and spare parts as needed.
• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships, and using clear communication to meet shared objectives.

We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:

• Associate degree in a technical field or acceptable trade certification.
• 3-5 years of GMP manufacturing facility experience supporting maintenance in the biotechnology or pharmaceutical industry.
• Firsthand experience with CMMS software including Blue Mountain Regulatory Asset Manager.
• Experience with (Desigo CC) Building Management software strongly preferred.
• Good working knowledge of Steam Boilers, RODI/EDI, Vapor Compression Stills, HVAC and O&M requirements.
• Experience with using Microsoft Excel and Microsoft word.
• Strong understanding of proper OSHA safety practices and procedures
• Willingness to put internal customer needs first.
• Great attention to detail leaving no loose ends in workload.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
• Willingness to think outside of the box and adapt best practices to increase efficiencies.
• Ability to adapt in a constantly evolving environment.
• Initiative-taking with a strong sense of ownership in areas of responsibility.

Why Should You Apply?