The Manager, Production Maintenance is responsible for providing direction and daily supervision of production maintenance staff, planning equipment 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.
Responsibilities May Include
- Establishes and communicates a clear vision for a fully integrated and high performing production maintenance team that is aligned with the strategic objectives and business goals for QuVa Pharma
- Ensures effective and compliance operations in accordance with site registrations, GMP and environmental regulations and state requirements
- Effectively develops and leads the Production Maintenance team to provide site services with accountability for execution of equipment maintenance activities and calibrations to enable the QuVa Pharma operations and other support functions to meet or exceed business expectations in cost, quality, compliance, safety, culture and capital
- Leads the area of production maintenance from onboarding equipment through decommissioning via CMMS and related procedures
- Defines and implements necessary production 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 equipment 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
- Other duties as assigned by leadership
Qualifications
- Legally authorized to work in the job posting country
- Bachelor of Science in Engineering related field, or equivalent Science or Manufacturing Management related field, or a combination of education and industry experience
- 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 is preferred
- Cleanroom Certification Requirements (ISO 14644) is preferred
- Computerized Maintenance Management System (CMMS) principles
- Equipment/Instrument Calibration principles
- Experience working with PLC’s, HMI’s, Robotics, and SCADA systems
- Lean 6 Sigma knowledge and ability to utilize root cause analysis tools
- Cleanroom Design, Operation and Maintenance
- Experience with pharmaceutical grade compressed air systems
- Knowledge with local and state regulatory requirements
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.
