Join the team at BioPharma Consulting JAD Group as a Maintenance Technician Senior. In this role, you will be responsible for overseeing the maintenance and repair of equipment and systems used in the biopharmaceutical industry. You will work closely with the Facilities & Engineering Department to ensure equipment reliability and compliance with regulatory requirements. This is a senior-level position that requires extensive experience and knowledge in maintenance practices and procedures related to biopharmaceutical manufacturing.
Responsibilities:
Maintain and repair all production mechanical equipment
Support the maintenance, operation, and repair of all systems, subsystems, and equipment within the Amgen 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 Amgen 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
Developing, writing, and completing various quality systems and safety documentation such as: Standard Operating Procedures (SOP), Change Control (CCMS), Non-Conformance (NC), Work Orders (WO), Job Plans (JP), Hazard Risk Assessments (HRA), Job Hazard Assessments (JHA), etc
Required to know, comprehend, and apply packaging configurations, as well as understand, follow and document batch records for the inspection and packaging process
Reconcile components and products, and calculate product exposure to room temperatures
Skills:
Strong documentation and attention to detail skills
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
Precision machinery experience highly preferred
Electro-mechanics/electrical background
Troubleshooting experience (electrical or mechanical)
GMP background and cleanroom experience
Ability to create, read, interpret, and revise engineering documents
Strong writing skills for preparing technical reports and documentation
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 gases 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
Requirements
Qualifications:
Associate degree with 4 years of experience OR
High school diploma / GED with 6 years of experience
Shift:
Night Shift (4 nights on, 3 nights off)
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Manufacturing
Industries
Non-profit Organizations and Primary and Secondary Education
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