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At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.  We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action; we believe that good business means a better world.

 

The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution.)

Relocation benefits are available for this job posting.

 

Under the direction of Mechanical Services Manager or other site leadership, perform a wide variety of tasks and operations that are required to formulate, fill and inspect sterile pharmaceutical products in a state-of-the-art, automated production facility.

Troubleshoot and maintain, all instrumentation and control systems as required. Lead or Assist on equipment upgrades, repairs, and installations as necessary. All operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), and Genentech standards.

In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits:

Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers.
Continuously in search of ways to maintain the highest levels of productivity and share those best practices with other employees.
Actively participate in a teamwork environment that maintains a high performance culture.
Growth mindset and appetite for learning
Main Accountabilities:

Responsible for the maintenance and calibration of all instrumentation and control system equipment within the Hillsboro Oregon facility to include utilities, filling equipment, packaging equipment.
Support the maintenance, operation and repair of all systems, subsystems, and equipment within the Genentech, Hillsboro Oregon facility.
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 operated 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.

Ensure / maintain all assigned equipment areas in a constant state of inspection readiness; specifically, but not limited to, the following:
-Cleanliness.

-Personnel and Equipment Safety

-Compliance to cGMP requirements.

Continuously evaluate the operation of all systems and associated subsystems at Genentech Hillsboro. Identify specific process improvement needs and provide recommendations for system upgrades.
Identify training deficiencies, provide recommendations for training and where applicable provide training.
Continuously evaluate all Standard Operating Procedures, engineering drawings and various other controlled documentation for accuracy and applicability. Submit appropriate change requests to supervisor to correct any deficiencies discovered.
Continuously evaluate maintenance/calibration practices to eliminate non productive activities and implement productivity enhancements.
Perform troubleshooting of electrical, pneumatic, and mechanical equipment.
Complete preventive maintenance and assigned paperwork in a timely manner following all cGMP documentation guidelines.
Provide diagnostics, repairs and modifications of industrial process control instrumentation.
Assist with design and perform detailed evaluations of new instrumentation and process control systems.
Perform instrument calibrations in accordance with standard operating procedures.
Prepare and organize technical documentation and operational procedures.
Perform Confined Space Entry on an as needed basis.
Work in close proximity to hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery/equipment.
Coordinate contractors who perform repairs, modifications, and installations of various equipment.
Work directly with Manufacturing, Engineering and various Quality organizations on new system installations or modifications and maximize equipment availability.
Conduct work in an FDA regulated environment.
Must possess the ability to create, read, interpret and revise engineering documents.
Comfortable using software platforms to capture calibration data and recording work performed, as well as software to modify and/or program instruments.
Comfortable working with manufacturers to obtain required programming software and hardware as necessary.
Working knowledge of electrical switchgear and distribution systems in the medium to low voltage range.
Qualifications / Requirements

Must have a working knowledge of Predictive Maintenance philosophy and techniques.
Must posses a thorough knowledge of the fundamental operating principles of industrial process instrumentation and process control systems.
Must be proficient in ISA standards and practices for instrumentation
Must posses a thorough knowledge of PID control theories and techniques, relay ladder logic and programmable controllers.
Install, maintain, and troubleshoot relay logic, ladder diagrams, control components– photo eyes, motor starters, relays, limit switches, proximity sensors, timers, solenoids, Servo drives, frequency converters, linear drives, tachometers, and encoders.
Ability to read and understand P & lDs, operate Delta-V and MES systems.
A practical knowledge of computer aided manufacturing automation.
Must posses the ability to read, interpret and produce engineering documents.
High School diploma or equivalent.
Completion of an approved 2-year instrumentation or industrial Engineering curriculum at a technical school, or an AA/AS Degree in a related science or engineering major, plus a minimum of 2 years progressive experience in manufacturing process control instrumentation or closely related jobs with a proven performance record.
Thorough knowledge of the fundamental operating principles of industrial process instrumentation systems.
8 to 12 plus years experience in the operation of complex mechanical equipment in an industrial / manufacturing maintenance/operation environment. Experience in pharmaceutical, biotechnology, biomedical, semi-conductor, and chemical, food processing, cosmetics, and/or other medical industries a plus.
Thorough knowledge of cGMP compliance.
Must posses advanced documentation skills to ensure project files and system documentation is maintained at a superior level
Practical understanding of OSHA, NEC, State and Federal regulations as applied to the equipment and operation.
Thorough working knowledge of Federal, State, Local, procedures, and policies associated with industrial waste, bulk chemicals / gasses, refrigerants and hazardous waste.
Proficient in Microsoft Word, Excel, Access, Filemaker Pro, and various Allen-Bradley VFD and PLC software packages.
Must continuously demonstrate the ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, varying electrical voltages and moving machinery.
Knowledge of and ability to use Computerized Maintenance / Calibration Management Systems.
Must have general knowledge of shop tool operation and safety.
Ability to read and Understand P&lDs, work from Standard Operating Procedures (SOPs) and have basic computer skills using word processors, spreadsheets, databases, and email.
Ability to perform maintenance and instrument calibrations according to Standard Operating Procedures
Must be detail oriented and demonstrate good record keeping practices.
Ability to work overtime or temporarily modify shift schedule to support manufacturing operations as needed.
Working knowledge of electrical switchgear and distribution systems in the medium to low voltage range.
Demonstrate effective writing skills including preparing technical reports, the revision of various technical documentation and procedures.
Ability to work overtime or temporarily modify shift schedule to support manufacturing operations as needed.
Effectively work with minimum or no supervision.
Strong interpersonal skills are a must.
Ability to lift up to 50 pounds.

To apply for this job please visit careers.gene.com.