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Maintenance Technician Senior

2 months ago

Thousand Oaks, United States The Steely Group Full time
Job DescriptionJob Description

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

Requirements / Qualifications:

  • Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
  • 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
  • Strong writing skills for preparing technical reports and documentation
  • Ability to partner with and become a resource to customers
  • 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
  • Ability to read and understand P&IDs, work from SOPs, and use basic computer skills
  • Knowledge of and ability to use Computerized Maintenance Management Systems
  • Detail-oriented and organized with good record-keeping practices
  • Effective communication skills and ability to work with minimum or no supervision
  • Capable of multi-tasking and working overtime or temporarily modifying shift schedule as needed
  • Ability to lift up to 50 pounds, climb ladders, and work at elevations up to 15 feet
Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.