Instrumentation/Calibration Specialist

Job Summary:

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

Job Responsibilities

• Develop, review, and approve preventative maintenance, calibration, and/or cleaning procedures for Utility, Process, QC and Metrology equipment and systems.

• Collaborate with maintenance and engineering staff in the continuous improvement of technical infrastructure required to support Utility equipment and systems, including specifications, procedures, and implementation of best maintenance practices.

• Lead or support discrepancy evaluations, CAPAs, and Quality investigations.

• Develop and maintain training content and structure for utilities maintenance and operations personnel

• Participate in design, implementation, commissioning and qualification of process/utility equipment systems.

• Collaborate with site and Corporate Engineering on facility modifications, process expansions and new installations.

• Interact and communicate with Manufacturing, Quality, Technology, and Engineering to ensure satisfactory performance of process equipment/systems.

• Review, assess, and approve Change Records and Maintenance related Documents.

• Provide engineering technical expertise and guidance to other technical staff members.

• Provide flexible and on-call support of 24x7 operations, as needed.

Job Requirements

Education/Experience:

• BA/BS or equivalent in a scientific or engineering discipline with a minimum of 5 years of experience in Utilities, Maintenance and/or Instrumentation, or 10 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

Knowledge/Skills/Competencies

• Strong proficiency in maintenance principles and techniques, and demonstrated ability in successfully applying that knowledge.

• Strong 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.

Work Environment/Physical Demands/Safety Considerations

• Must be able to work weekends, off shifts, and overtime as required to support a 24x7 manufacturing operation

• Must be able to lift 50 lbs., push/pull 100 pounds of force

• Must be able to stand or sit for extended periods of time

• Must be able to climb stairs and walk for extended periods of time

• Must be able to perform computer work with heavy mouse use

• Must be able to meet gowning requirements such as safety glasses, full gowns, steel toes boots, etc. No makeup or jewelry of any kind can be worn inside the manufacturing plant.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.