Manager, Production Maintenance 1st Shift

RXinsider LTD.; New Jersey; On-site; USD 99,000 - 136,000; Full time

Benefits offered by this job

Health benefits

401(k) plan with company match

Paid time off: 22 days + 8 holidays

Bonus eligibility

Job summary

Quva is seeking a Manager, Production Maintenance to lead a high-performing maintenance team, ensure GMP compliance, and align maintenance activities with the site’s 5-year plan. This role engages cross-functionally with Operations, QA, and Regulatory teams to deliver safe, compliant, and cost-effective plant performance.

Minimum requirements include a B.S. in engineering, 3 years in pharma maintenance leadership, and experience with CMMS, PLCs, and lean methodologies.

Qualifications

• Bachelor of Science in Engineering or equivalent Manufacturing/Science experience.
• 3 years of experience managing a team in pharmaceutical environments.
• CMMS principles and calibration principles.
• Experience with PLCs, HMIs, robotics and SCADA systems.
• Lean Six Sigma knowledge and RCA tools.
• Cleanroom design, operation and maintenance.
• Experience with pharmaceutical grade compressed air systems.
• Knowledge of local/state regulatory requirements.
• Able to lift up to 50 lbs and pass background checks.
• Authorized to work in the United States full-time; no sponsorship.

Responsibilities

• Provide direction and daily supervision of production maintenance staff.
• Plan equipment maintenance activities per schedules.
• Lead cross-functional site initiatives and 5-year site plan.
• Manage CMMS processes from onboarding to decommissioning.
• Drive 503B outsourcing facility standards and regulator engagement.
• Develop staff through coaching and performance management.
• Support site metrics and continual process improvement.

Skills

Leadership

CMMS

Calibration principles

PLCs/HMI/Robotics/SCADA

Lean 6 Sigma

Cleanroom design

Pharma regulatory knowledge

Physical stamina

Communication

Education

Bachelor of Science in Engineering related field

Tools

CMMS software

Job description

Our Manager, Production Maintenance, 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 The Manager, Production Maintenance is responsible for providing direction and daily supervision of production maintenance staff, planning equipment maintenance activities in accordance with schedules agreed upon, 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 to 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 Production 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, Production Maintenance Does Each Day

• 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 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

Our Most Successful Manager, Production Maintenance

• Has strong technical writing skills and verbal/written communication skills, including presentation skills
• Successfully establishes priorities, allocates resources, and develops action plans to support day-to-day operation and drive improvement
• Utilizes analytical, critical thinking and structured root cause analysis techniques for problem solving
• Demonstrates expertise in project management
• Meets challenges and develops innovative approaches
• Influence others

Minimum Requirements For This Role

• 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 toolsli>
• 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
• 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

Any Of The Following Will Give You An Edge

• Experience in the facility and utility standards for the pharmaceutical industry
• Cleanroom Certification Requirements (ISO 14644)

Benefits Of Working At Quva

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• A minimum of 22 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities
• 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
• Range: $98,891 - $135,975 Annually
• This position is bonus eligible based on set criteria

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.”

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