Employer: Genentech
Job Description:
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.)
Under the direction of Mechanical Services Manager or other site leadership, you will 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.
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 encoders. You will lead or assist on equipment upgrades, repairs, and installations as necessary. Operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), and Genentech standards. Advanced documentation skills are necessary to ensure system information is maintained at a superior level.
The ideal candidate will possess a working knowledge of cGMP compliance, Predictive Maintenance philosophy & techniques, fundamental operating principles of industrial process instrumentation and process control systems. Individuals should also possess the ability to read, interpret and produce engineering documents and understand P&IDs, operate Delta-V and MES systems.
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 calibration of all instrumentation and control system equipment within the facility to include utilities, filling equipment, packaging equipment and QC lab equipment.
Support the maintenance, operation and repair of all systems, subsystems, and equipment within the 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:
Continuously evaluate maintenance/calibration practices to eliminate nonproductive activities and implement productivity enhancements.
All instrument calibrations are performed at the appropriate interval in accordance with SOPs and are 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 compliance to cGMP requirements.
Continuously evaluate the operation of all systems and associated subsystems. 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 (SOPs), engineering drawings and various other controlled documentation for accuracy and applicability. Submit appropriate change requests to the supervisor to correct any deficiencies discovered.
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.
Demonstrate effective writing skills including preparing and organization of technical reports, the revision of various technical documentation and operational procedures.
Perform 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 as necessary to capture calibration data and recording work performed, as well as software to modify and/or program instruments. Ability to work with manufacturers to obtain training.
Minimum Requirements:
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 or closely related jobs with a proven performance record.
3 years related operation or manufacturing experience.
Preferred Qualifications:
5 years progressive experience in manufacturing process control instrumentation, preferred.
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 or closely related jobs with a proven performance record.
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, semiconductor, and chemical, food processing, cosmetics, and/or other medical industries a plus.
A practical knowledge of computer aided manufacturing automation, OSHA, NEC, State and Federal regulations as applied to the equipment and operation.
Ability to work overtime or temporarily modify shift schedule to support manufacturing operations as needed. Ability to lift up to 50 pounds.
Proficiency in ISA standards and practices for instrumentation, and various Allen-Bradley VFD and PLC software packages is highly desirable. Individuals should also possess thorough knowledge of relay ladder logic and programmable controllers; as well as shop tool operation and safety.
Ability to read and Understand P&lDs, work from SOPs and have basic computer skills using word processors, spreadsheets, databases, and email.
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, electrical switchgear and distribution systems, varying electrical voltages and moving machinery / equipment. Knowledge of and ability to use Computerized Maintenance / Calibration Management Systems.
Relocation benefits are NOT available for this job posting.
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.
Contact Person: John Gray
Phone: 503-708-5136
Email: [email protected]
Location:
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Application Method: Apply Online
Base Pay: $85,000 to $90,000/year
