Production Maintenance Mechanic II 1st Shift

QuVa Pharma•Bloomsbury, NJ

51d•$32 - $51•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

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

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
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

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