Manager, Facilities Maintenance

Quva • Bloomsbury, NJ

24d • $98,891 - $135,975

About The Position

Our Facilities Maintenance Manager is responsible for providing direction and daily supervision of maintenance staff, planning maintenance activities in accordance with agreed upon schedules, strategic planning sessions and development of site 5-year plan aligned with company vision and strategic direction. This position will have indirect, cross-functional involvement with all Operations and have opportunities to align systems and processes ensure effective and efficient controls are in place to support regulatory compliance (i.e. 21CFR210 and 211), 503B compounding pharmacy registration and business operations. The Facilities Maintenance Manager will engage with other members of site management to ensure that the site platform for quality, compliance and operational efficiency are embedded across the site and visible through departmental and site metrics for the Maintenance Operations. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. What the Manager, Facilities Maintenance Does Each Day: Establishes and communicates a clear vision for a fully integrated and high performing facilities maintenance team that is aligned with the strategic objectives and business goals for Quva Ensures effective and compliance operations in accordance with site registrations, GMP and environmental regulations and state requirements Effectively develops and leads the Quva Facilities Maintenance to provide site services with accountability for execution of facility, utility and equipment maintenance, Calibration and certifications to enable the Quva operations and other support functions to meet or exceed business expectations in cost, quality, compliance, safety, culture and capital Responsible for routine operation and maintenance of site infrastructure including BMS and fire/security systems (24/7 Operation) Leads the area of facilities & utilities maintenance from onboarding through decommissioning via CMMS and related procedures Defines and implements necessary facilities maintenance practices; as well as drive industry standards with regards to 503B outsourcing manufacturing facilities through participation and engagement with regulators, industry subject- matter experts on facility operations, knowledge and principles from other related industry segments that utilize controlled environments and aseptic manufacturing Stays current with industry trends and identifies opportunities for workforce development and continued education for staff Effectively executes projects that improve quality, safety, product cost, risk reduction and plant capabilities. This includes the development and preparation of required cGMP documentation required for the ongoing facility, equipment, and utility maintenance programs. Assures completion of all phases a project in a timely and efficient manner Networks and partners effectively internally with cross-functional disciplines (Procurement, Technical Support, Manufacturing, Quality, Finance, IT) as well as externally with customers, suppliers, and regulators to ensure compliance with company policies, procedures, and regulatory requirements, as well as promote an organizational culture that supports the achievement of business objectives Develops direct reports and builds a high-performance team through utilization of a performance management process that sets expectations, ensures ongoing coaching/mentoring and assesses employee performance Supports development of site and departmental metrics to gauge ongoing performance of organization and identification of opportunities for continual process improvement Supports and maintains systems in compliance with local and state regulatory bodies associated with wastewater, sewer, emissions, waste handling/storage and disposal

Requirements

• Bachelor of Science in Engineering related field, or equivalent Science or Manufacturing Management related field, or a combination of education and industry experience
• Knowledgeable in: Computerized Maintenance Management System (CMMS) principals
• Equipment/Instrument Calibration Principals
• Honeywell EBI BMS
• Cleanroom Design, Operation and Maintenance
• Physical security such as access control, CCTV and site building alarm systems
• Site Fire Suppression System
• Pharmaceutical grade compressed air systems
• Local and state regulatory requirements
• Direct experience working on: Large scale mechanical systems (HVAC/Refrigeration)
• 200 Ton Chillers
• 20,000 CFM Air Handlers
• 20,000 CFM Exhaust Systems
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas
• Have strong technical writing and verbal/written communication skills
• Develop action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics
• Possess time management skills & expertise in project management
• Utilize analytical, critical thinking and structured root cause analysis techniques for problem solving

Nice To Haves

• 3 years of experience managing a team specializing in pharmaceutical environment as well as experience in the facility and utility standards for the pharmaceutical industry
• Experienced in Cleanroom Certification Requirements (ISO 14644)

Responsibilities

• Establishes and communicates a clear vision for a fully integrated and high performing facilities maintenance team that is aligned with the strategic objectives and business goals for Quva
• Ensures effective and compliance operations in accordance with site registrations, GMP and environmental regulations and state requirements
• Effectively develops and leads the Quva Facilities Maintenance to provide site services with accountability for execution of facility, utility and equipment maintenance, Calibration and certifications to enable the Quva operations and other support functions to meet or exceed business expectations in cost, quality, compliance, safety, culture and capital
• Responsible for routine operation and maintenance of site infrastructure including BMS and fire/security systems (24/7 Operation)
• Leads the area of facilities & utilities maintenance from onboarding through decommissioning via CMMS and related procedures
• Defines and implements necessary facilities maintenance practices; as well as drive industry standards with regards to 503B outsourcing manufacturing facilities through participation and engagement with regulators, industry subject- matter experts on facility operations, knowledge and principles from other related industry segments that utilize controlled environments and aseptic manufacturing
• Stays current with industry trends and identifies opportunities for workforce development and continued education for staff
• Effectively executes projects that improve quality, safety, product cost, risk reduction and plant capabilities. This includes the development and preparation of required cGMP documentation required for the ongoing facility, equipment, and utility maintenance programs.
• Assures completion of all phases a project in a timely and efficient manner
• Networks and partners effectively internally with cross-functional disciplines (Procurement, Technical Support, Manufacturing, Quality, Finance, IT) as well as externally with customers, suppliers, and regulators to ensure compliance with company policies, procedures, and regulatory requirements, as well as promote an organizational culture that supports the achievement of business objectives
• Develops direct reports and builds a high-performance team through utilization of a performance management process that sets expectations, ensures ongoing coaching/mentoring and assesses employee performance
• Supports development of site and departmental metrics to gauge ongoing performance of organization and identification of opportunities for continual process improvement
• Supports and maintains systems in compliance with local and state regulatory bodies associated with wastewater, sewer, emissions, waste handling/storage and disposal

Benefits

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 22 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities
• Salary Range based on experience $98,891- $135,975

What This Job Offers

• Job Type: Full-time
• Career Level: Manager