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.)
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 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.
You will provide 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.
You will support the maintenance, operation and repair of all systems, subsystems, and equipment within the facility
You will provide support to engineering and operations in the design, installation, testing, operation and maintenance of Fill Finish manufacturing and support equipment
You will ensure all assigned equipment and associated subsystems are operated and maintained in the following manner:
Continuously evaluate maintenance/calibration practices to eliminate non productive 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
You will ensure / maintain all assigned equipment areas in a constant state of inspection readiness with focus on cleanliness, personnel and equipment safety, and compliance to cGMP requirements
You will continuously evaluate the operation of all systems and associated subsystems. Identify specific process improvement needs and provide recommendations for system upgrades
You will continuously evaluate all Standard Operating Procedures (SOPs), engineering drawings and various other controlled documentation for accuracy and applicability. Submit appropriate change requests to supervisor to correct any deficiencies discovered
You will perform troubleshooting of electrical, pneumatic, and mechanical equipment
You will complete preventive maintenance and assigned paperwork in a timely manner following all cGMP documentation guidelines
You will assist with design and perform detailed evaluations of new instrumentation and process control systems
You will coordinate contractors who perform repairs, modifications, and installations of various equipment
Who you are:
You have a technical degree or certification in Instrumentation / Industrial Automation or equivalent
You possess a working knowledge of cGMP compliance, Predictive Maintenance philosophy & techniques, fundamental operating principles of industrial process instrumentation and process control systems
You have an ability to read, interpret and produce engineering documents and understand P&IDs, operate Delta-V and MES systems
You are knowledgeable in all types of instrumentation, automated systems, lab equipment, and understand the tools and standards that are specific to each piece of equipment to perform planned maintenance tasks, specifically a thorough working knowledge 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.
Preferred Qualifications
You have 1-4 years’ experience in instrumentation calibration and repair in a regulated industry
You have 1-4 years' experience in an Instrument shop environment in a lead or supervisory role.
You have proficiency with a Computerized Maintenance Management System (CMMS) and Calibration Management Program, preferably with SAP PM
Relocation benefits are not available for this position.
The Position
At Roche, we advance science so that we all have more time with the people we love.
The Opportunity:
Become a Genentech/Roche member of a collaborative team that creates outcomes that matter for patients, customers and the company. This chemistry position will join the exciting and fast-paced Quality Control Operations team in Hillsboro Technical Operations.
Perform testing/review of general chemistry assays that include HPLC/UPLC.
Maintain laboratory equipment
Implement improvement opportunities that support Quality Control.
Perform other duties as requested by managers to support QC activities.
Who You Are:
BS/BA Degree in Chemistry with at least 5 years of work experience in similar roles.
Sound knowledge of cGMPs or equivalent Regulations. A minimum of 2 year of experience working in a GMP environment is required.
Must have strong verbal and written communication skills.
Must have the ability to interpret and apply quality standards to operational activities.
Work Environment / Physical Demands / Safety Considerations
Prolonged periods of standing at lab bench top. Frequent lifting (up to 25 lbs), bending, reaching, twisting, climbing stairs. Use of step ladders and push carts required.
Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
Pass visual screening, as required
This position is NOT eligible for relocation benefits.
The expected salary range for this position based on the primary location of Oregon is $66,900 to $124,200. 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.