What are the responsibilities and job description for the GMP Equipment Specialist position at Endo?
About Endo
As a leader in the healthcare industry, Endo strives to develop and deliver high-quality life-enhancing products. We have a team of nearly 3,000 global employees who understand the importance of their role in delivering healthcare and are dedicated to supporting each other as we work to bring forward innovative treatments.
Job Responsibilities
- Execution of corrective and preventative maintenance of all critical GMP and non-critical GMP instrumentation and controls for plant utilities and GMP manufacturing equipment such as fermenters, process vessels, purification equipment, autoclaves, component washers, and other ancillary manufacturing equipment.
- Maintenance of the operation and integrity of all critical utilities and GMP equipment systems, including HVAC, refrigeration, boilers, steam and hot water systems, chillers, compressed air systems, nitrogen systems, purified water, and clean steam systems.
- Preventative and corrective maintenance of GMP manufacturing equipment, lab, and warehouse equipment according to ENDO Engineering standard operating procedures.
- Response to building alarms, security alerts, and GMP equipment issues 24/7, with occasional off-hours emergencies.
- Development and revision of Standard Operating Procedures (SOPs) for preventative maintenance of Critical Utilities and GMP equipment.
- Monitoring of Siemens and Johnson Controls Building Automation Systems and response to system issues and critical alarms in a timely manner.
- Daily walk-throughs and monitoring of critical utility areas serving the GMP manufacturing and warehouse facilities.
- Assistance in troubleshooting mechanical and automated GMP equipment issues to ensure optimal functionality while adhering to cGMPs.
- Scheduling of maintenance contractors as required and supervision of onsite work.
- Timely and accurate closeout of Preventative and Corrective maintenance work orders in the Computerized Asset Management System (CAMS).
- Assistance in identifying and purchasing spare parts using COUPA.
- Attendance at training seminars and courses as required.
Requirements
- 2-year technical school degree or equivalent experience; high school diploma or equivalent required.
- HVAC training preferred.
- General electrical wiring/installation training preferred.
- Minimum 3 years' experience as a Maintenance Mechanic or equivalent trade.
- Experience working in a GMP environment and completion of GMP documentation required.
