Production Maintenance Mechanic III 2nd Shift
About The Position
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 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 2PM to 10:30 PM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Bloomsbury, NJ location.
Requirements
- 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 applicants for work visas
Nice To Haves
- 4+ years prior experience in cGMP / FDA regulated industry
- 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
- Preventive Maintenance (PM) or Total Productive Maintenance (TPM) training is a plus
- Advance Industrial Maintenance Technology Certification or Equivalent preferred
- Maintenance & Reliability Certification
Responsibilities
- 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
