Phoenix, Arizona, United States
Lead maintenance operations across aseptic manufacturing areas, ensuring adherence to cGMP standards and regulatory requirements. Manage preventive maintenance programs, system upgrades, troubleshooting, and equipment calibration in a sterile injectable environment. Oversee execution of work orders, ensuring quality, accuracy, and on-time completion. Develop and revise SOPs, lead internal audits, and manage compliance documentation in enterprise quality systems. Provide technical mentorship and OJT to maintenance staff and new hires. Collaborate with vendors for equipment upgrades, technical support, and root cause analysis.
Performed complex maintenance on cGMP manufacturing equipment including filling lines and formulation systems. Created and maintained accurate GMP documentation and technical work instructions. Supported equipment installation, commissioning, and validation for capital improvement projects. Executed root cause analysis and implemented corrective actions for recurring issues.
Maintained and troubleshot manufacturing and utility systems including boilers, HVAC, WFI, and cleanroom equipment. Implemented efficiency improvements and preventative maintenance strategies to reduce downtime. Supported compliance with OSHA, EPA, and FDA regulations through rigorous QA practices. Partnered with vendors for spare part sourcing and system upgrades.
Performed A/C system retrofits, evacuations, and pressure testing on public transit buses. Conducted precision measurements and hose replacements in articulated bus joints. Ensured compliance with mechanical specifications and safety standards.
Operated and maintained zero-discharge water treatment systems and conducted water chemistry adjustments. Supported major overhauls of steam turbines (HP/IP/LP) and gas turbines. Performed start-up/shutdown of GT, HRSG, condensate, and steam systems for peak efficiency. Ensured optimal water chemistry for power plant operations and system longevity.
Assembled gas compressor components in accordance with detailed specifications. Conducted hydrostatic testing on key components including bearing housings and end caps. Maintained strict quality assurance and safety standards during assembly.