Vice President, Engineering and Maintenance
The position will be responsible for corporate engineering and facilities management with direct involvement across the company’s manufacturing platform regarding facility capital projects and strategic planning initiatives, facilities design and compliance, equipment and technology continuous improvement and innovation, facility maintenance and Environmental, Health and Safety.
The incumbent must be able to lead and direct a team of qualified individuals with core competencies to assess and implement solutions focused on increasing available facility/production line capacity, technology enhancements and reducing operating costs in line with overarching company-wide initiatives, within established budgets and timelines, and in accordance with cGMP, OSHA, EPA, DEA and other regulations and industry standard practices.
The position will provide direct guidance and oversight for new and existing capital projects for national Operations with specific emphasis on the expansion of manufacturing capabilities to meet corporate growth objectives across facilities and equipment. The position will also be responsible for establishing processes and systems, and assuring their smooth and compliant operation, for maintenance, calibration and repair at all sites. Oversight includes engineering project management, facility and equipment capital budgeting, monitoring and measuring performance, governing maintenance groups at all sites, establishing policies and procedures, and standardizing practices across the manufacturing network. The individual must work cooperatively with parallel functions including Operations, Quality Assurance, Supply Chain Management, Human Resources, Technical Operations, Information Technology and Pharmacy Services.
Responsibilities may include:
- Reports directly to COO
- Provides direct, hands-on leadership, oversight and execution of Facilities Engineering and Maintenance activities
- Establishes systems, policies and procedures for facilities maintenance and engineering related matters assuring management reporting through the development of metrics and performance indicators to monitor and trend result, 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 are deeply embedded within processes, systems and controls to support day to day manufacturing operations and assure continuous compliance
- Establishes and communicates a clear vision for a fully integrated and high performing team that is aligned with the 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
- Responsible for developing and implementing skills and techniques needed to maintain, troubleshoot and provide suggestions for improvement of all infrastructure and equipment including automated, and semi-automated PLC controlled equipment.
- Effectively executes projects that improve quality, safety, product cost, risk profile and plant capabilities. This includes the development and preparation of required cGMP documentation required for the maintenance, engineering and facility projects as well as the ongoing facility, equipment and utility maintenance programs. Provides oversight to assure completion of all phases of projects in a timely and efficient manner in line with budget expectations
- Networks and partners effectively with cross-functional disciplines 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
- Other duties as assigned
- Legally authorized to work in the job posting country
- 15+ year of experience in an engineering and maintenance function in a manufacturing setting within the pharmaceutical industry and 7+ years of supervisory experience
- Bachelor of Science in Engineering related field required
- Experience in Cleanroom Design, Operation and Maintenance
- Direct experience working on large scale mechanical systems (HVAC/Refrigeration/BMS)
- Experience with Site Fire Suppression Systems including dedicated pumping station and water storage systems
- Experience executing of multi-million dollar facility-related projects, experience managing a maintenance team within the pharmaceutical environment as well as experience in the facility and utility standards for the pharmaceutical industry
To be considered:
In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.
Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.
It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.