Principal Maintenance Specialist, Compounding and Filling - CVRM (Holly Springs)
Core
Lead troubleshooting and issue resolution for highly complex mechanical challenges in pharmaceutical compounding and filling equipment, establishing maintenance programs, and mentoring staff during plant start-up and operations.
Role type
Principal Maintenance Specialist (Pharmaceutical Compounding and Filling)
Builds
High-volume, highly-efficient Drug Product manufacturing lines for Cardiovascular, Renal, and Metabolism medicines.
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
Mechanical aptitude, troubleshooting complex machinery, cGMP compliance, SOP creation, team coaching/mentorship, spare parts management, P&ID reading, aseptic processing principles
Preferred skills
A.A./A.S./Trade School Certificate, experience with high-performance pharmaceutical filling lines, AI/digital tools proficiency
Technologies
SAP, SAP S4/HANA, PLC/automation systems
Responsibilities
Establish site maintenance program and procedures for compounding/filling equipment; perform planned preventative maintenance and repairs on GMP assets; support FATs for equipment; create continuing education and training for maintenance staff; identify spare parts and BOM improvements; support Quality Record management; input master data into SAP.
Seniority
Principal, hands-on IC with mentorship responsibilities
