Job Title: Instrumentation and Equipment Specialist II
Location: Philadelphia, PA
Shift: 3rd Shift - Wednesday – Saturday, 10:00 PM – 9:00 AM
Compensation: $81,000 - $86,000 base salary, 18% shift differential, and a 10% annual bonus.
Education: Bachelor's degree with 5 years of related experience, or an Associate's degree with 10 years of related experience
Top 3 Skills:
Experience: 5-10 years of instrumentation and equipment experience in a GMP environment.Systems Experience: Proficiency with Computerized Maintenance Management Software (CMMS) such as Blue Mountain. Familiarity with Building Management Systems (Siemens Desigo, Insight) and Environmental Monitoring Systems.Technical Skills: Experience troubleshooting and maintaining mechanical, HVAC, electrical, and process systems, with a focus on calibration, metrology, and troubleshooting.Overview: We are seeking an experienced Instrumentation and Equipment Specialist II to join our team. This critical role supports the maintenance, calibration, and repair of equipment, utilities, and systems essential to our cGMP Manufacturing, Laboratories, and Warehouse operations. You will perform planned and corrective maintenance, troubleshoot issues in real-time, and ensure all systems remain compliant with safety and GMP standards. This is a facility-based position, requiring adherence to safety protocols, including the use of personal protective equipment (PPE) and respiratory protection.
Key Responsibilities:
- Perform preventative, routine, and corrective maintenance on process utility systems, manufacturing instruments, and laboratory equipment.
- Calibrate, adjust, and maintain measuring and indicating instruments to ensure they conform to required standards, with a focus on calibration/metrology processes.
- Troubleshoot and repair PLCs, HVAC systems, mechanical equipment, and electrical systems.
- Conduct routine inspections of the facility, equipment, and systems to ensure optimal performance.
- Monitor and respond to alarms from the Building Management System (BMS) and Environmental Monitoring Systems (QEMS).
- Apply technical knowledge and root cause analysis to investigate Out of Tolerance (OOT) events and implement corrective actions.
- Review and interpret engineering and architectural drawings, including P&IDs, power plans, and mechanical/plumbing diagrams.
- Maintain compliance with building codes and safety regulations when conducting maintenance or repairs.
- Write incident and deviation reports, performing root cause analyses and identifying corrective actions when necessary.
- Work with external vendors to coordinate equipment service and repairs.
- Participate in the “On-Call” rotation for emergency support.
- Ensure compliance with all safety protocols, including OSHA regulations and company SOPs.
Required Qualifications:
- Education: Bachelor's degree with 5 years of related experience, or an Associate's degree with 10 years of related experience.
- Experience: 5-10 years of instrumentation and equipment experience in a GMP environment.
- Systems Experience: Proficiency with Computerized Maintenance Management Software (CMMS) such as Blue Mountain. Familiarity with Building Management Systems (Siemens Desigo, Insight) and Environmental Monitoring Systems.
- Technical Skills: Experience troubleshooting and maintaining mechanical, HVAC, electrical, and process systems, with a focus on calibration, metrology, and troubleshooting.
- Certifications: Ability to wear clean room attire and all necessary PPE (scrubs, gowning, masks, gloves, etc.).
- Communication Skills: Strong oral and written communication skills.
- Additional Requirements: Valid driver's license and the ability to support emergency shifts.
Preferred Qualifications:
- Experience in cell therapy manufacturing or the biopharma/life sciences industry.
- Familiarity with ISO/IEC 17025, ANSI/NCSL 3, and 21 CFR Part 11 regulations.
- Knowledge of GxP best practices and FDA regulations.
- Previous experience using Blue Mountain CMMS is a plus.