Senior Analytical Instrumentation Specialist

Lonza•Vacaville, CA

4d•Onsite

About The Position

The Senior Analytical Instrumentation Specialist serves as the key liaison between instrumentation owners, Engineering, Quality, Procurement, and external service providers to ensure the reliable, compliant, and efficient operation of analytical equipment supporting QC, MSAT, and Manufacturing. This role coordinates preventive maintenance, calibration, repairs, vendor services, and equipment lifecycle activities, while ensuring CMMS accuracy, GMP compliance, and inspection readiness. Working closely with cross-functional teams, the incumbent manages equipment performance, qualification impacts, change controls, vendor effectiveness, and maintenance KPIs to drive continuous improvement, maximize asset reliability, and support uninterrupted laboratory and manufacturing operations.

Requirements

High School Diploma or GED required.
Apply advanced technical knowledge of analytical instrumentation and maintenance practices to troubleshoot and resolve complex equipment issues.
Collaborate with Manufacturing, Quality, and Engineering teams to support cross-functional decision-making and equipment reliability.
Utilize CMMS, calibration management systems, and business software applications (Microsoft Office); SAP experience preferred.
Ensure compliance with GMP regulations, data integrity requirements, and site quality standards for analytical instrumentation.
Support regulatory inspections and audits (FDA, EMA, etc.) by maintaining compliant documentation and maintenance records.
Demonstrate strong planning, scheduling, and coordination skills to effectively manage maintenance activities and service providers.

Nice To Haves

Associate degree in a technical discipline preferred.

Responsibilities

Serve as the primary point of contact for QC, MSAT, and Manufacturing equipment owners, coordinating equipment support and issue resolution.
Plan and manage preventive maintenance, calibration, repair, and vendor service activities to ensure equipment reliability and compliance.
Coordinate with service providers and contractors to troubleshoot equipment issues, minimize downtime, and maintain operational readiness.
Oversee vendor performance, contractor compliance, service agreements, onboarding, and laboratory access requirements.
Manage procurement activities, including quotations, purchase requisitions, purchase orders, and service-related expenditures.
Maintain CMMS data integrity, equipment records, work orders, maintenance history, and asset performance metrics.
Ensure GMP compliance and inspection readiness by supporting qualification assessments, change controls, deviations, CAPAs, audits, and regulatory requirements.