Sr. Instrumentation and Equipment Specialist (3rd shift)
300 Rouse Boulevard Philadelphia, PA 19112 US
Job Description
Overview
The Sr. Instrumentation and Equipment Specialist is responsible for the maintenance, calibration and repair of equipment, utilities and systems supporting cGMP Manufacturing, Laboratories and Warehouse. Perform planned and corrective maintenance and calibration according to written instructions, diagnose issues in the field in real-time, propose corrective solutions, and complete and review related Facilities GMP documents. Ensure the safety and compliance of all applicable systems.
Primary Responsibilities
- Perform preventative, routine and corrective maintenance of CTU’s, process utility systems, and manufacturing/laboratory instruments.
- An understanding of calibration / metrology and the ability to calibrate, adjust, and maintain measuring and indicating instruments to conform to set standards is highly desirable.
- An understanding of PLC’s, HVAC, mechanical and electrical systems, and be able to troubleshoot and repair is highly desirable.
- Perform routine inspections of the facility, equipment and systems.
- Monitor, investigate and respond to alarms generated from the BMS/QEMS.
- Knowledge in the use of a wide range of standards, including temperature, relative humidity, differential pressure, CO2, flow, conductivity, resistivity, speed, time, pressure, and weight is highly desirable.
- Support Metrology to investigate OOT events using root cause analysis, metrics, technical knowledge and historical experience to identify and remediate.
- Ability to read and interpret engineering and architectural drawings, including floor plans, reflected ceiling plans, power plans, panel schedules, mechanical/plumbing piping diagrams, Piping & Instrumentation Diagrams (P&IDs)
- Write incident/deviation reports as necessary, perform root cause analyses and identify corrective actions as appropriate.
- Receive, filter and execute work order requests as necessary.
- Ensure that any equipment repairs or maintenance activities are compliant with any applicable building codes.
- Work with external vendors for the service and/or repair of equipment.
- Provide “On-Call” support as needed.
- Other duties as required.
Position Requirements
- Bachelor’s degree with 5 years of experience / Associates Degree with 10 years of experience is required.
- 5-10 years of related instrumentation and equipment experience in a GMP environment is required. Prior experience in cell therapy manufacturing or BioPharma/Life Sciences is highly desirable.
- Experience using Computerized Maintenance Management Software (Blue Mountain) is required.
- Experience using Building Management Systems and Environmental Monitoring Systems (Siemens Desigo or Insight) is required.
- Experience working under ISO/IEC 17025 and/or ANSI/NCSL Z540.3 management systems is preferred.
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations is preferred.
- Excellent oral and written communication skills required.
- Must have valid driver’s license
Physical Requirements
- Stand for long periods of time
- Ability to squat, crawl and climb ladders
- Ability to lift 50lbs.
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