Overview:
We are seeking a skilled GMP Maintenance Technician to join our team in ensuring the smooth operation of our facilities within a Good Manufacturing Practices (GMP) environment. The ideal candidate will have a strong background in maintenance and repair work within GMP standards. This role requires meticulous attention to detail, adherence to safety protocols, and the ability to work effectively in a regulated manufacturing environment.
Equipment Maintenance: Perform routine and preventive maintenance on equipment, including HVAC systems, roll-up door mechanics within Non- GMP and GMP environments, utilities, and facility systems to ensure optimal performance and compliance with GMP standards.
Troubleshooting and Repairs: Diagnose and troubleshoot equipment malfunctions, electrical issues, plumbing problems, and other maintenance-related issues promptly to minimize downtime and interruptions.
Documentation and Recordkeeping: Maintain accurate records of maintenance activities, repairs, inspections, and equipment performance data in compliance with GMP documentation standards. Update maintenance logs, work orders, and equipment manuals as necessary.
Safety and Compliance: Adhere to safety protocols, standard operating procedures (SOPs), and regulatory guidelines to maintain a safe working environment and ensure compliance with GMP regulations. Participate in safety training programs and contribute to the development of safety protocols.
Emergency Response: Respond promptly to maintenance emergencies, such as equipment breakdowns, power outages, and facility issues, to mitigate risks and minimize disruptions to manufacturing operations. Collaborate with cross-functional teams to resolve critical issues efficiently.
Inventory Management: Monitor and maintain adequate inventory levels of spare parts, tools, and supplies necessary for maintenance activities. Coordinate with procurement and supply chain teams to ensure timely replenishment of stock and optimize inventory levels.
Continuous Improvement: Identify opportunities for process optimization, efficiency improvements, and cost-saving initiatives within the maintenance function. Propose and implement solutions to enhance equipment reliability, reduce downtime, and streamline maintenance processes.
Preferred Qualifications:
High school diploma or equivalent; technical certification or vocational training in maintenance or related field preferred.
Proven experience as a maintenance technician in a GMP-regulated environment, such as pharmaceuticals, biotechnology, or food manufacturing.
Strong mechanical, electrical, and plumbing skills with the ability to troubleshoot and repair equipment effectively.
Familiarity with maintenance management systems (CMMS), computerized control systems, and basic hand tools.
Excellent communication skills and the ability to work independently or collaboratively in a team environment.
Attention to detail, organizational skills, and a commitment to quality, safety, and compliance.
Flexibility to work occasional evenings, weekends, or overtime as needed to support maintenance activities and production schedules.
Ability to lift and carry heavy objects, climb ladders, and work in confined spaces as required.