JT420 - SR. MAINTENANCE TECHNICIAN
Quality Consulting Group
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
- Installation, maintenance, troubleshooting, repair, and continuous improvement of manufacturing equipment, utility systems, supporting bacterial fermentation, purification, and related GMP manufacturing operations.
- Execute advanced maintenance activities or operate assigned equipment, facility, utility, and HVAC Systems in accordance with established guidelines and operating procedures.
- Conduct intermediate troubleshooting and employ advanced predictive technologies to identify root cause and appropriate corrective actions to diagnose or avert equipment problems.
- Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team is responsible for.
- Perform various ""Housekeeping"" activities, (i.e. keeping work areas clean, cleaning of equipment etc.)
- All work must be completed in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies.
- Maintain an up-to-date cGMP training book.
- Develop, revise, and review SOPs or job plans/work plans for work related areas.
- Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program.
- Trouble shoot and repair equipment/system failures
- Interpret and review utility, process system/ equipment, plumbing, ductwork plans, architectural, and HVAC P&ID's.
- Basic support and may start-up of new equipment to ensure it meets all mechanical design specifications.
- Assist with the development and execution of validation documents for mechanical equipment.
- Support on-call response by maintaining a pager or cell phone while on-call.
- Associate degree in Mechanical, Electrical, Industrial Maintenance, Mechatronics, or related technical field; or equivalent military/industry experience.
- 5+ years of maintenance experience in pharmaceutical, biotechnology, food, chemical, or regulated manufacturing environments.
- The role requires strong technical expertise, hands-on execution, documentation compliance, and the ability to support production while maintaining safety, quality, and regulatory standards.
- Experience supporting fermentation, bioprocessing, utility, and process equipment.
- Demonstrated ability to work independently and lead complex maintenance activities.
- Strong understanding of GMP requirements and documentation practices.
- Experience in bacterial fermentation or microbial manufacturing operations.
- Knowledge of CIP/SIP systems and sterile manufacturing practices.
- Experience with PLC-controlled equipment and automation systems.
- Reliability-centered maintenance (RCM) experience.
- Lean Manufacturing or Continuous Improvement experience.
- Technical certification in maintenance, instrumentation, electrical, or mechanical disciplines.
- Non-standard 2nd and 3rd shift (5:00Pm to 5:30 AM)
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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