Production Maintenance Mechanic II 1st Shift

Quva-Pharma; Sugar Land (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

401k with company match

Paid time off (17 days) + 8 holidays

Job summary

Quva-Pharma is seeking a Production Maintenance Mechanic II for the 1st shift in Sugar Land, TX. You will maintain and troubleshoot cleanroom equipment, follow aseptic gowning procedures, and ensure compliance with cGMP/FDA standards.

Responsibilities include real-time CMMS documentation, maintaining calibration schedules, and adhering to SOPs to sustain sterile manufacturing operations. The role requires 5–7 years in maintenance/engineering, cleanroom experience, and US work authorization.

Qualifications

• High School Diploma or equivalent required.
• 5-7 years experience in Maintenance or Engineering.
• 3 years Cleanroom experience/aseptic gowning procedures.
• 3 years experience in a cGMP/FDA regulated industry.
• Able to pass drug and background check; US work authorization required.

Responsibilities

• Performs and coordinates planned and demand maintenance on production and cleanroom equipment following SOPs.
• Documents all maintenance work in the CMMS.
• Ensures work orders are completed within specified timeframes.
• Performs preventative maintenance on production equipment per WI/SOPs.
• Maintains equipment lists, calibration schedules, and spare parts inventory.
• Troubleshoots and repairs equipment; coaches production staff on technical aspects.
• Maintains safe working practices including LOTO; adheres to regulatory standards.

Education

High School Diploma or equivalent

5-7 years in Maintenance/Engineering

3 years Cleanroom/aseptic gowning

3 years in cGMP/FDA regulated industry

Tools

CMMS

PLCs/HMIs/SCADA

OSHA/Electrical certs

Job description

Production Maintenance Mechanic II 1st Shift

Job Category: 7000-Operations Support

Requisition Number: PRODU006077

• Full-Time
• On-site

Locations

Showing 1 location

TX - Sugar Land 1075
1075 W Park One Dr #100
Sugar Land, TX 77478, USA

Description

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 2:00 PM to 10:30 PM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Sugar Land, TX 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
• 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

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
• OSHA, Maintenance, or Electrical Certifications

Benefits of Working at Quva:

• 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

About Quva:

Quva is a national, industry-leading provider of compounded injectable medicinesand 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 BrightStreampartners with health-systems to analyze large amounts of data and through AI and machine learning,develops softwaresolutions 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.”

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.