Sr Facilities Manager.US-BOS.001 - Integra LifeSciences

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.

Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.

But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.

At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra’s ongoing commitment to our values and our shared success.

Integra’s health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.

Regardless of geographic location, our commitment is to offer the following, whenever possible:

• Benefit plans that meet all local statutory requirements
• A range of programs that reflect typical local market practices
• An opportunity for employees to tailor benefits to their specific needs
• Benefits that balance employee’s short-term and long-term needs

Click HERE for more information regarding our benefits and total rewards program

• Manage Facilities at both South Boston and New Facility in Braintree, MA
• Manage Direct Reports: Facilities Specialist, Facilities Technician, Shuttle Drivers
• Conduct Performance Reviews and Talent Management Process
• Recommend Staffing Requirements and support new hire process
• Cross-Train Existing Staff
• Strategically plan Facility capabilities to support new business & technology growth. Recommend new more efficient equipment as needed.
• Manage relationships with Facility related contacts, establish new strategic suppliers, and coordinate internal and vendor Facility related activities to effectively service the needs of the manufacturing, administration, engineering, and management groups.
• Participate in Site Walk-Thru’s both inside and outside Cleanroom.
• Responsible for Building, Facility Equipment, Utilities, Offices Areas, Wastewater, and ISO Class 7 Clean Room Utilities/Conditions are operational, maintained, and compliant.
• Coordinate with & Support Engineering, EHS, Manufacturing, Quality, IT, and Supply Chain Departments.
• Responsible for Facility Cleanliness/Housekeeping; Management of Janitorial Service Contractor.
• Responsible for Clean Room Cleaning Contract Service, Scheduling, and Compliance.
• Responsible for Site Security
• Lead and/or support CAPA, Non-Conformance, DCN’s related to facility
• Prepare and submit summary reports of conditions in buildings and recommend actions to be taken.
• Report on assigned KPI’s
• Maintain information flow throughout the Site on facility issues and emergencies.
• Manage building emergencies such as plumbing, electrical, air conditioning, building health and environmental issues.
• Understand, control and ensure all utilities and associated equipment are operating properly to support ISO class 7 clean room activities.
• Implement Preventative and Predictive Maintenance Programs for Facility Equipment.
• Act as the primary owner interface with building landlords and their site management.
• Setup or re-arrange floor layouts to facilitate lean office configurations 
• Manage all Facility Department related budgets, expenses, and invoicing.
• Drive all facility related continuous improvement projects.
• Established budget and accurate spending projections, manage within capital and operating resources and able to identify significant capital spend requirements during budget preparation.
• Create and maintain cGMP records to ensure Integra requirements are compliant.
• Act as SME for any Clean Room/Facility related audit activity. Responsible for knowledge of and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation, ISO 13485 and ISO 9001standards, OSHA and the EPA.
• Function as the primary liaison with Building and Fire departments, utilities and insurance representatives, and other inspectors

• Bachelor’s Degree preferred   
• Ability to be 100% on-site is required. 
• 10+ years of experience in pharmaceutical or medical device facility operations management
• Internal Customer Service Mentality
• Exceptional Follow-Up Skills displaying a high sense of urgency
• Elevated attention to detail
• Experience in new GMP site startup, GMP commissioning and GMP validation. Comprehensive understanding and experience in startup, shutdown, operation and maintenance of ISO7 and ISO 8 Clean Rooms Facilities.
• Management of facilities equipment repair/preventive maintenance programs.
• Proven success in managing and delivering cross-functional tasks with effective liaison between EH&S, IT, Security and Procurement, including external contractors, vendors, professional consultants, and Fire/Building/Planning/governmental agencies
• Proficient in Root Cause Analysis (RCA) and Failure Modes and Effects Analysis (FMEA).
• Experience writing CAPA’s, NC’s, and DCN’s
• Knowledge of GMPs, FDA guidelines, purchasing practices and process validation.
• Knowledge of troubleshooting HVAC, refrigeration, purified water, electrical, and mechanical systems.
• Knowledge on personal computer and software like MS Word, Excel and Power Point
• Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience
• Strong written, verbal and interpersonal skills
• Exceptional practical problem-solving skills, and communication skills

Relocation available!

In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.