Production Maintenance Mechanic III 1st Shift

Production Maintenance Mechanic III 1st Shift

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Our Production Maintenance Mechanic III plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities include performing maintenance, troubleshooting, and working on 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 compliant 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.

• 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
• Maintain 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

• 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

• High School Diploma or equivalent required:
  Associates degree or higher preferred
• 7+ years prior experience in Maintenance or Engineering field
• 4+ years experience in cleanroom operations with Aseptic gowning procedures
• 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…