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Sr. Instrumentation and Equipment Specialist (3rd shift)

Philadelphia, PA 19112

Posted: 08/31/2023 Employment Type: Direct Hire/Perm Job Category: Scientific Job Number: 571687 Is job remote?: No Country: United States

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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Philadelphia, PA

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.