Description de l'offre
Candidates must be available to work any shift, including weekends, nights and holidays. Currently, this shift is expected to be Swing shift, Wed-Sat. and is subject to change.
· Responsible for the maintenance and calibration of all instrumentation and control system equipment within the Hillsboro Oregon facility to include utilities, Aseptic filling, Packaging, Automated Inspection and QC laboratory instruments.
· Provide complex emergency troubleshooting and complex repairs of all the HTO site control systems and instruments in the areas of Filling, Packaging, Inspection, QC, Tank Management, Utilities, Warehouse and Distribution Center.
· 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:
· 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 improvement, develop new training materials and provide calibration OJT training to N1s, N2s and N3s.
· 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.
· Create new Maintenance Strategy SOPs and Work Instructions as required.
· Continuously evaluate maintenance/calibration practices to eliminate non productive activities and implement productivity enhancements.
· Perform Confined Space Entry on an as needed basis.
· Complete assigned scheduled and corrective maintenance in a 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 instrumentation, control systems, and associated equipment.• Perform installations of new complex instrumentation and process control equipment.
· Perform complex instrument calibrations in accordance with standard operating procedures.
· Perform Variable Frequency Drive replacements and configurations.
· Perform complex 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.
· Participate in functional teams and cross functional teams as instrument subject matter expert support.
· Identify and implement process improvements within functional group which improves inspection readiness, productivity, reduces time bound maintenance, or eliminates non- value added activities.
· Use project management skills to complete complex improvement projects by their due dates.
· Must have full working knowledge of Predictive Maintenance philosophy and techniques.
· Must possess full knowledge of the fundamental operating principles of industrial process instrumentation and process control systems. Understands impact of equipment and system changes and alarms through BAS, DCS, Delta V, local and/or loop controllers and PI Process Book.
· Respond and resolve more complex problem troubleshooting and repairs of all the HTO site control systems including Filling, Packaging, Inspection, QC, Tank Management, Utilities, Warehouse and Distribution Center. Able to recognize and effectively communicate repetitive repair issues to management and provide solutions to reoccurring repair issues. Ability to work on complex assignments and solve problems within situations ordinarily encountered. Typically makes decisions within established policies and procedures.
· Must be proficient in ISA standards and practices for instrumentation
· Must possess a thorough working knowledge of PID control theories and techniques, relay ladder logic and programmable controllers.
· A full knowledge of computer aided manufacturing automation.
· Must possess the ability to create, read, interpret and revise engineering documents.
· 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 strong documentation and attention to detail skills to ensure work orders, GMP compliance, safety and other regulatory documents are readable and error free.
· Practical understanding of OSHA, NEC, State and Federal regulations as applied to the equipment and operation.
· Proficient in Microsoft Word, Excel, SAP, Gmail, Calendar, gWiz, DocLink, CEDM, TrackWIse, 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.
· Thorough working knowledge of system hazardous energy isolation to lead and perform LOTO of all the HTO site process systems.
· Knowledge of and ability to use Computerized Maintenance (SAP) and Calibration Management Systems.
· Must have full knowledge of shop tool operation and safety.
· Ability to read and Understand P&lDs, work from Standard Operating Procedures (SOPs) and have comprehensive 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.
· Full knowledge of electrical switchgear and distribution systems in the medium to low voltage range and full knowledge of electrical safety requirements to be able to work safely on electrical systems rated at less than 600 volts and lead electrical troubleshooting events.
· 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, assess, make decisions based on existing procedures and communicate actions taken.
· Demonstrated ability to make appropriate decisions in the absence of management's guidance. Typically makes decisions within established policies and procedures.
· 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.
· Ability to lead groups in execution of projects.
· Ability to support large cross functional groups in execution of projects.
· Demonstrated ability to lead and train other technicians in skills necessary for fully proficient in their roles.
· Assists lead and other management personnel in tasks/personnel coordination.
· Effectively work with general supervision. Minimal instructions or direction required on routine work and more detailed instructions given for new activities or special assignments.
· Ability to work overtime or temporarily modify shift schedule to support manufacturing operations as needed.
Who You Are (Qualifications):
· 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 3 years experience in manufacturing process control instrumentation or closely related jobs with a proven performance record, for Sr. level position.
· Thorough knowledge of the fundamental operating principles of industrial process instrumentation systems.
· Thorough knowledge of ISA principals and standards.
· Strong interpersonal skills are a must.
· Proficiency in both oral and written communications is essential.
· Ability to lift up to 50 pounds
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
If you have a disability and need an accommodation in connection with the on- line application process, please email us at
· Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.