Contract duration 12 months with possible extensions
Shift: Wednesday – Friday & every other Saturday, 6:00pm to 6:30am, (subject to change due to business needs)
Responsible for the maintenance and calibration of all instrumentation and control system equipment within the Hillsboro Oregon facility to include utilities, Filling, Packaging, and Inspection instruments.
Provide instrument issue resolution, emergency troubleshooting and repairs of all the HTO site control systems and instruments in the areas of Filling, Packaging, and Inspection.
Provide support to engineering and operations in the design, installation, testing, operation and maintenance of Fill Finish manufacturing and support equipment.
Ensure all assigned equipment and associated subsystems are rated and maintained in the following manner:
All instrument calibrations are performed at the appropriate interval and is completed by the assigned due date.
All equipment remains in its designed and/or validated state at all times.
All equipment operation is in accordance with Federal, State, Local and Genentech regulations, procedures, and policies.
Perform Confined Space Entry on an as needed basis.
Complete assigned scheduled and corrective maintenance in a timely manner following all cGMP documentation guidelines.
Perform installations of new instrumentation and process control equipment.
Perform instrument calibrations in accordance with standard operating procedures.
Perform Variable Frequency Drive replacements and configurations.
Perform configuration of the site’s instrumentation.
Work directly with Manufacturing, Engineering and various Quality organizations on new system installations or modifications and maximize equipment availability.
Conduct work in a GMP regulated environment.
Must possess knowledge of the fundamental operating principles of industrial process instrumentation and process control systems.
Respond and resolve instrument problem troubleshooting and repairs of all the HTO site control systems including Filling, Packaging and Inspection.
Able to use working knowledge and thorough understanding of the site’s control systems to recognize and effectively communicate all repair issues to management.
Must possess the ability to create, read, interpret and revise engineering documents.
Must possess documentation and attention to detail skills to ensure work orders, GMP compliance, safety and other regulatory documents are readable and error free.
Ability to read and Understand P&IDs, work from Standard Operating Procedures (SOPs) and have computer skills using word processors, spreadsheets, databases, and email.
Ability to perform maintenance and instrument calibrations according to Standard Operating Procedures and Work Instructions.
Able to adjust all the site’s instruments and repair instrument malfunctions.
Proficiency in understanding of Federal, State, Local and Genentech regulations, procedures, and policies.
Demonstrate writing skills including preparing technical reports, creation of new complex documents, the revision of various technical documentation and procedures.
Demonstrates a strong ability to partner with and become a resource to customers.
Anticipates, identifies and defines needs. Demonstrated ability to take ownership of customer’s problem.
Effectively work under general supervision. Manager provides work priorities, timelines and resources.
Ability to lift up to 50 pounds.
Ability to work overtime or temporarily modify shift schedule to support manufacturing operations as needed.
• Attend all required cGMP training as required by Department Policy
• Attend all required Safety training as required by Department Policy
• Complete on-the-job training Using established training procedures
To apply for this job please visit careers.gene.com.