Maintenance Specialist - Instrumentation

Lonza•Vacaville, CA

6d•$95,000 - $153,000•Onsite

About The Position

The Instrumentation/Calibration Maintenance Specialist will provide technical support for calibration/maintenance and related equipment or system improvements and modifications, act as Training Owner and Quality Record owner for Utilities Instrumentation related IFM activities, and will support cross-functional project teams in the delivery of expense/capital projects at the Vacaville Manufacturing Facility. The Instrumentation/Calibration Maintenance Specialist may interact with and successfully present information to domestic and international regulatory agencies.

Requirements

BA/BS or equivalent in a scientific or engineering discipline with a minimum of 3 years of experience in Utilities, Maintenance and/or Instrumentation, or 5 years of equivalent experience in a related industry.
Comprehensive knowledge of safety principles and quality systems in a highly regulated manufacturing environment.
Minimum 3 years working in a GMP manufacturing environment, ideally providing maintenance support on Drug Product or Drug Substance equipment
Strong proficiency in maintenance principles and techniques, and demonstrated ability in successfully applying that knowledge.
Technical leadership and ability to work independently or as part of a multidisciplinary team.
Experience in engineering documentation such as P&IDs and Design Specifications related to process equipment and systems.
Effective communication and interpersonal skills with Maintenance, Technical, Operations, Quality, and senior management.

Responsibilities

Develop and approve maintenance, calibration, and cleaning procedures for all utility and process systems.
Lead quality investigations, CAPAs, and discrepancy evaluations to ensure regulatory compliance.
Oversee training programs and content development for all instrumentation and metrology personnel.
Manage technical documentation, including the review and approval of change records and maintenance files.
Drive continuous improvement by implementing best maintenance practices and infrastructure specifications.
Partner with engineering on the design, commissioning, and installation of new equipment or facility expansions.
Provide technical expertise and cross-functional support to ensure optimal performance of 24/7 operations.