"Alerted.org

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:

+ Maintain and repair all production mechanical equipment.

+ Support the maintenance, operation, and repair of all systems, subsystems, and equipment within the Fill / Finish facility.

+ Provide support to engineering and operations in the design, installation, testing, operation, and maintenance of Fill Finish manufacturing and support equipment.

+ Ensure all assigned equipment and associated subsystems are maintained in accordance with Federal, State, Local, and regulations, procedures, and policies.

+ Maintain all assigned equipment areas in a constant state of inspection readiness.

+ Identify training deficiencies and provide recommendations and training where applicable.

+ Continuously evaluate and improve maintenance practices and documentation.

+ Perform troubleshooting of electrical, pneumatic, and mechanical equipment.

+ Complete preventive maintenance and assigned paperwork following all cGMP documentation guidelines.

+ Coordinate contractors for repairs, modifications, and installations of equipment.

+ Work directly with Manufacturing, Engineering, and Quality organizations on new system installations or modifications.

+ Attend all required cGMP and Safety training.

+ Maintain qualifications as assigned.

Qualifications:

+ Associate degree and 2 years of experience OR 2 years in a technical school setting with hands-on experience OR High school diploma

+ Thorough working knowledge of pharmaceutical filling, freeze drying, and packaging equipment operation, maintenance, and repair.

+ Full working knowledge of pumps, valves, mechanical seals, motors, and proper lubrication

+ Strong documentation and attention to detail skills.

+ Full working knowledge of cGMP and Predictive Maintenance philosophy and techniques

+ Ability to create, read, interpret, and revise engineering documents, P&Ids and SOPs.

+ Strong writing skills for preparing technical reports and documentation.

+ Ability to identify and implement process improvements.

+ Familiarity with machine shop equipment including CNC machine and lathe is a plus.

+ Ability to work safely with hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, varying electrical voltages, and moving machinery.

+ Knowledge of and ability to use Computerized Maintenance Management Systems.

+ Ability to lift up to 50 pounds, climb ladders, and work at elevations up to 15 feet.

+ Multiple Shifts:

+ Sunday through Tuesday and every other Wednesday 5am-6pm

+ Thursday through Saturday every other Wednesday 5am-6pm

+ Sunday through Tuesday every other Saturday 5pm-6am.

+ Wednesday through Friday every other Saturday 5pm-6am.

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.

Powered by JazzHR