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


Job Description Summary

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, maintain, and assemble all production equipment as required. Lead or Assist on major equipment overhauls, 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
Job Responsibilities

Responsible for the maintenance and repair of all production mechanical equipment within the Genentech, Hillsboro Oregon facility.
Support the maintenance, operation and repair of all systems, subsystems, and equipment within the Genentech, Hillsboro Oregon Fill / Finish 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 maintained in the following manner:
– All Preventative maintenance is 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, and ComplianceIdentify training deficiencies, provide recommendations for training and where applicable provide training to technicians and other maintenance groups.
Continuously evaluate all associated Standard Operating Procedures, engineering drawings, and various other controlled documentation for accuracy and applicability.  Submit appropriate change requests to management to correct any deficiencies discovered.
Continuously evaluate maintenance/operational practices to eliminate non productive activities and implement productivity enhancements.
Perform troubleshooting/maintenance/calibration of electrical, pneumatic, and mechanical automated equipment.
Mechanical Capabilities

Install and rebuild various pumps, valves, and motors
Troubleshoot process piping leaks, CIP skids, Parts Washers, Autoclaves, Stopper Processors, Formulation Tanks, Filling equipment, Automated Inspection Machines and Trayloaders
Maintain and optimize mechanical drive trains, sensors and vacuum generation + distribution systems
Must have full working knowledge of pumps, valves, mechanical seals, motors and proper lubrication.
Automation Capabilities

Read/troubleshoot PLC programs, ability to troubleshoot ladder logic (read use for troubleshooting), components (CPU back plains, I/O boards, counters, modules, and devices) and communications modules (Ethernet)
Must have the ability to read and understand P&lDs, operate Delta-V and MES systems, and read and understand ladder logic for Allen Bradley and Siemens systems
Troubleshoot control components– photo eyes, motor starters, relays, limit switches, proximity sensors, timers, solenoids, Servo drives, frequency converters, linear drives, tachometers, and encoders

Perform Confined Space Entry on an as needed basis.
Complete preventive maintenance and assigned paperwork in a safe and timely manner following all cGMP documentation guidelines.
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.
At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
Job Requirements

High school diploma or equivalent AND
Graduate of a two-year Associates Degree program in Electrical/Mechanical Technology (or equivalent technical training)
Graduate of a 4 years Bachelors Degree program in Engineering is a plus, but not required.
Minimum of 12 years (within the last 14 years) experience in the operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers is highly desirable.  Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries.
Must have full working knowledge of Predictive Maintenance philosophy and techniques.
Must possess strong documentation and attention to detail skills to ensure work orders, GMP compliance, safety and other regulatory documents are readable and error free.
Demonstrates a full working knowledge of cGMP as pertains to job requirements. Must be very familiar with all the Maintenance SOPs and WIs required to perform their job requirements.
Must possess the ability to create, read, interpret and revise engineering documents.
Demonstrates strong writing skills including preparing technical reports, creation of new documents, the revision of various technical documentation and procedures.
Demonstrates full ability to partner with and become a resource to customers. Anticipates, identifies and defines needs. Demonstrated ability to take ownership of customer’s problems.
Demonstrates full ability to identify and implement more complex process improvements within each functional group which improves inspection readiness, productivity, reduces time bound maintenance, or eliminates non-value added activities. Ability to use project management skills to complete improvement projects by their due dates.
Must have thorough working knowledge of shop tool operation and safety.
Thorough knowledge of cGMP compliance.
Thorough working knowledge of pharmaceutical filling and inspection equipment operation, maintenance and repair.
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.
Must have the ability to work from Standard Operating Procedures (SOPs) and have basic computer skills using word processors, spreadsheets, databases, and email.
Ability to perform maintenance and equipment servicing according to Standard Operating Procedures
Knowledge of and ability to use Computerized Maintenance Management Systems.
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.
Thorough working knowledge of Federal, State, Local and Genentech regulations, procedures, and policies associated with industrial waste, bulk chemicals / gasses, refrigerants and hazardous waste.
Working knowledge of electrical switchgear and distribution systems in the medium to low voltage range.
Must have effective communication skills.
Effectively work with minimum or no supervision.
Must be detail oriented, organized and capable of multi-tasking
Ability to lift up to 50 pounds.
Must be able to climb ladders and work at elevations up to 30 feet.

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