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This position is responsible to maintain and improve and/or upgrade process and support equipment for biopharmaceutical manufacturing and aseptic filling operations. The role supports operations in ensuring use-ready and compliant equipment, including advanced troubleshooting, preventive maintenance, upgrade, and authoring, review, update, and completion of CMMS and GMP-related documentation.
Job Responsibility:
Troubleshoot complex problems, complete emergency repairs, and guide staff in implementing repairs
Maintain equipment in use-ready, compliant state. Major equipment includes lyophilizer, PLC, SCADA, HMI, clean steam, WFI, and others
Monitor, respond to, and correct issues generating equipment alarms
Provide recommendation for, and implement upgrades and improvements
Author, review, and update maintenance procedures and forms
Complete CMMS entries and required training activities
Travel between facilities to support all functional areas
Regular and reliable attendance on a full time basis [or in accordance with posted schedule]
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture
Requirements:
High school diploma or equivalent experience required
Minimum twelve (12) plus years of relevant experience required
Minimum eight (8) years of cGMP experience required
Mastery of troubleshooting
Mastery of process and support equipment for pharmaceutical manufacturing including lyophilization system, clean steam, WFI, PLC, SCADA, HMI, and others
Advanced understanding of cGMP
Ability to work in a group, and independently
Nice to have:
Certification preferred
What we offer:
paid time off
health insurance coverage (including dental and vision)