Director, Facilities & Engineering

About the role

The Director, Facilities & Engineering plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include site facilities and engineering management supporting the site manufacturing to include facilities management, HVAC, Electrical, controls, reliability, capital projects and workorder compliance.

Responsibilities

• Provides hands-on leadership, oversight, and execution of Facilities Engineering Operations
• Establishes policies and procedures for facilities and engineering related matters, assuring management reporting through the development of metrics and performance indicators to monitor and trend results, and taking actions to correct, prevent and/or improve execution and future performance
• Participates in development of strategic planning associated with development of site infrastructure to ensure capacity, capability, and compliance (C3) are deeply embedded within processes, systems and controls implemented to support day to day manufacturing operations
• Establishes and communicates a clear vision for a fully integrated and high performing team that is aligned with strategic objectives and business goals
• Ensures effective and compliant operations in accordance with site registrations, cGMPS and environmental regulations and state requirements acquiring and maintaining permits and certifications as necessary
• Proposes and develops capital project budgets to inform and protect business objectives
• Supports site management through the identification and introduction of facility upgrades and innovative solutions that drive continuous improvement
• Defines and implements necessary facilities improvements within the existing operation to maintain current cGMP and Industry Best 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
• Effectively executes projects that improve quality, safety, product cost, risk reduction and plant capabilities. This includes the development and preparation of the required cGMP documentation required for the engineering and facility projects as well as the ongoing facility, equipment, and utility maintenance programs
• Provides oversight to assure completion of all phases of a project in a timely and efficient manner in line with budget expectations
• Networks and partners effectively internally with cross-functional disciplines (Procurement, Technical Operations, Manufacturing, Quality, Finance, IT, HR) 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
• Overseeing facilities contracts, including monitoring performance, identifying risks, and developing documentation

Requirements

• 10+ years of experience in a manufacturing, production industry within pharmaceutical industry and 7+ years of supervisory experience
• Bachelor of Science in Engineering related field
• Cleanroom Design, Operation and Maintenance experience
• Direct experience working on large scale mechanical systems (HVAC/Refrigeration/BMS)
• Oversight of multi-million, dollar facility improvement projects, experience managing a team specializing in pharmaceutical environment as well as experience in the facility and utility standards for the pharmaceutical industry
• Occasional non-traditional work hours and travel required

Qualifications

• Must be currently authorized to work in the United States on a full-time basis; QuVa will not sponsor applicants for work visas

Skills

• Project Management skills (timelines, budget, and resource allocation)
• Analytical, critical thinking and structured root cause analysis techniques for problem solving
• Influences others

Benefits

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 25 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

About Quva

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.”