Manager, Production Maintenance 1st Shift

About the role

The Manager, Production Maintenance plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. This position involves providing direction and daily supervision of production maintenance staff, planning equipment maintenance activities, and developing a 5-year plan aligned with company vision and strategic direction.

Responsibilities

• 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 compliant operations in accordance with site registrations, GMP, and environmental regulations and state requirements.
• Develops and leads the Production Maintenance team to provide site services with accountability for execution of equipment maintenance activities and calibrations to enable Quva operations and other support functions to meet or exceed business expectations in cost, quality, compliance, safety, culture, and capital.
• Defines and implements necessary production maintenance practices; drives 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.
• Executes projects that improve quality, safety, product cost, risk reduction, and plant capabilities, including the development and preparation of required cGMP documentation required for the ongoing equipment maintenance programs; assures completion of all phases of 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, and promotes an organizational culture that supports the achievement of business objectives.
• Supports development of site and departmental metrics to gauge ongoing performance of the organization and identify opportunities for continual process improvement.

Requirements

• 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 environments.
• 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 of local and state regulatory requirements.
• Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation.
• Able to successfully complete a drug and background check.

Qualifications

• Minimum of 22 paid days off plus 8 paid holidays per year.
• Compensation range: $98,891 - $135,975 Annually.
• This position is bonus eligible based on set criteria.

Benefits

• Comprehensive health and wellness benefits including medical, dental, and vision.
• 401k retirement program with company match.
• Minimum of 22 paid days off plus 8 paid holidays per year.
• National, industry-leading high growth company with future career advancement opportunities.

Pay

The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions.

Schedule

At Quva, we offer a flexible schedule to accommodate your needs while ensuring productivity and success in your role.