Job Description

Production Maintenance Mechanic II 1st Shift

Our Production Maintenance Mechanic II 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 performing maintenance, troubleshooting, and of cleanroom-critical production equipment, including automated inspection, labeling, and packaging equipment. This role requires demonstrated capability in aseptic gowning procedures and to maintain compliance with cGMP and 503B pharmaceutical regulatory standards. The position ensures all equipment is maintained in validated state, operates within defined parameters, and complies with site SOPs, FDA regulations, and applicable quality standards. Responsibilities include real time documentation in CMMS, adherence to aseptic practices, and sustaining a clean and complaint workspace to support sterile manufacturing operations. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement.

This is a full-time role for our 1st shift, working Monday through Friday from 6:00 AM to 2:30 PM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Bloomsbury, NJ location.

What the Production Maintenance Mechanic II Does Each Day:

• Performs and/or coordinates planned and demand maintenance activities on production and cleanroom equipment while following all applicable SOP's
• Documents all maintenance work performed in site CMMS system
• Ensures maintenance work orders are completed within the timeframe specified
• Performs preventative maintenance on all production/manufacturing equipment following all applicable WI's/SOP's
• Maintains site equipment list as well as calibration and preventative maintenance schedules
• Maintains equipment spare parts list to ensure equipment reliability is always sustained
• Maintains systems including mechanical, electrical and pneumatic controls
• Troubleshoots and repairs faulty equipment parts
• Coaches manufacturing personnel on technical aspects of production equipment
• Recognizes priorities and acts, makes productive use of time
• Coordinates work orders activities by communicating with the organization via email
• Responds to issues after hours and during weekends
• Operates in a safe manner utilizing applicable LOTO Procedures
• Seeks opportunities to implement a culture of continuous process improvement as related to equipment, processes, and systems at the site
• Performs general maintenance activities repair of electrical, mechanical, plumbing and hardware within the site.
• Performs general maintenance activities including painting, wall patching, installation of fixtures in both production and office spaces
• Assists in root cause analysis and corrective actions for equipment failures
• Works in Clean Room Environments and obtains gowning certification

Our Most Successful Production Maintenance Mechanic II:

• Has a sense of urgency, accountability, and resourcefulness (e.g., work in changing environment)
• Is a self-starter and independent learner
• Promotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform

Minimum Requirements for this Role:

• High School Diploma or equivalent required
• 5-7 years prior experience in Maintenance or Engineering field
• 3 years Cleanroom experience/aseptic gowning procedures
• 3 years experience in a cGMP/FDA regulated industry
• 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 will not sponsor applicants for work visas

Any of the Following Will Give You an Edge:

• Computerized Maintenance Management System (CMMS) principles
• Experience working with PLC's, HMI's, Robotics, and SCADA systems
• Equipment/Instrument Calibration principles
• OSHA, Maintenance, or Electrical Certifications

Benefits of Working at Quva:

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• 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: $31.85 - $50.95 / Hour

About Quva:

Quva is a national, industry-leading provider of compounded injectable medicines and software solutions that help power the business of hospital and health-system pharmacy. Quva Pharma produces and distributes injectable medicines required by health care providers and critical to patient care. Quva BrightStream partners with health-systems to analyze large amounts of data and through AI and machine learning, develops software solutions that turns the data into insights that are used to better run their pharmacy operation. Quva's overall product and technology offerings help health-systems achieve greater value and deliver the 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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