The Position

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.

Hillsboro Technical Operations (HTO) focuses on Drug Product manufacturing (Component Prep and compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products, and Distribution).

Tuesday- Friday (10 hours a day) from 7:00am - 5:30pm

The Opportunity:

This position will work under the direction of the ES&T Maintenance Manager or other site leadership. In this role you will 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, pressure, temperature and flow transmitters and lab equipment.

You will lead or assist on equipment upgrades, repairs, and installations as necessary. Operations will comply with cGMPs, Standard Operating Procedures (SOPs), and Genentech standards. Advanced documentation skills are necessary to maintain system information at a superior level.

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

Passion and aim to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customersContinuously in search of ways to maintain the highest levels of productivity and share those standard processes with other employeesActively participate in a teamwork environment that maintains a high-performance culture, Growth mindset, and appetite for learning.Responsible for the maintenance, calibration and advanced troubleshooting of all instrumentation and control system equipment within the facility to include utilities, filling equipment, packaging equipment, and lab equipment.Support the maintenance, operation, and repair of all systems, subsystems, and equipment within the facilityProvide support to engineering and operations in the design, installation, testing, operation and maintenance of Fill Finish manufacturing and support equipmentEnsure all assigned equipment and associated subsystems are operated and maintained in the following manner:Continuously evaluate maintenance/calibration practices to eliminate nonproductive activities and implement productivity enhancementsAll instrument calibrations are performed at the appropriate interval following SOPs and are completed by the assigned due date.All equipment remains in its designed and/or validated state at all timesAll equipment operation is in accordance with Federal, State, Local, and Genentech regulations, procedures, and policiesEnsure/maintain all assigned equipment areas in a constant state of inspection readiness with a focus on cleanliness, personnel and equipment safety, and compliance with cGMP requirementsContinuously evaluate the operation of all systems and associated subsystems. Identify specific process improvement needs and provide recommendations for system upgradesIdentify training deficiencies, provide recommendations for training, and, where applicable, provide trainingContinuously evaluate all Standard Operating Procedures (SOPs), engineering drawings, and other controlled documentation for accuracy and applicability. Submit appropriate change requests to the supervisor to correct any deficiencies discoveredPerform troubleshooting of electrical, pneumatic, and mechanical equipmentComplete preventive maintenance and assigned paperwork in a timely manner, following all cGMP documentation guidelinesProvide diagnostics, repairs, and modifications of industrial process control instrumentationAssist with design and perform detailed evaluations of new instrumentation and process control systemsDemonstrate effective writing skills, including preparing and organization of technical reports, the revision of various technical documentation and operational proceduresPerform Confined Space Entry on an as-needed basis.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.Comfortable using programming software and hardware to capture calibration data, recording work performed, and software to modify and/or program instruments. Ability to work with manufacturers to obtain training

Who you are:

The ideal candidate will understand cGMP compliance, Predictive Maintenance philosophy and techniques, and the fundamental operating principles of industrial process instrumentation and process control systems. Individuals should also be able to read, interpret, and produce engineering documents, understand P&IDs, and operate Delta-V and MES systems.

You hold a Technical degree or certification in Instrumentation / Industrial Automation or equivalent.

Preferred

1-4 years experience in instrumentation calibration and repair in a regulated industry1-4 years experience in an Instrument shop environment in a lead or supervisory role.Proficiency with a Computerized Maintenance Management System (CMMS) and Calibration Management Program, preferably with SAP PM 

Knowledge, Skills, and Abilities

Must be knowledgeable in all types of instrumentation, automated systems, and lab equipment, and understand the tools and standards that are specific to each piece of equipment to perform planned maintenance tasks, specifically a thorough, solid understanding of the following: Instrumentation including pressure, level, temperature, flow, and analytical instrumentation, low voltage electrical and control circuits, primary standards, control valves and positioners, DeltaV, PLCs, lab equipment, etc.Ability to read and understand P&IDs, Standard Operating Procedures (SOPs), and Schematics; advanced computer skills using word processors, spreadsheets, databases, and email.Must continuously demonstrate the ability to work safely and monitor work being performed in an environment containing hazardous chemicals, high- and low-temperature liquids, high-pressure liquids and gases, steam, varying electrical voltages, and moving machinery.Knowledge of and ability to use Computerized Maintenance Management Systems.Proficiency in both oral and written communication is important.Must be detail-oriented and demonstrate good record-keeping practices.Demonstrate effective writing skills, including preparing technical reports and revising technical documentation and procedures.Must be knowledgeable about industry standards for instrumentation and electricalThe ability to create detailed maintenance plans and procedures for instrumentation, including tools, materials, parts, standards, and resources for multiple pieces of equipment,  instrumentation, and automation within manufacturing and the facilityHands-on experience performing maintenance and repair activities on instrumentation, automation, and equipment in a regulated industryKnowledge of maintenance and instrumentation strategies and techniquesDetail-oriented individual with the ability to meet deadlines on several activities simultaneously in a fast-paced environmentStrong communication, mathematical, organizational, and problem-solving skillsStrong understanding of mechanical and electrical engineering concepts in a manufacturing environment, preferably an aseptic or clean manufacturing facilityRead and interpret construction, engineering P&IDs, and schematic drawingsUse a wide variety of computer applications including Google Doc Applications, Word, PowerPoint, Excel, etc.Expert knowledge of instrumentation maintenance and asset management. Best Practices in a Regulated Environment

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of Oregon is 58,400-108,400  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

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.