Senior Instrumentation Calibration Technician

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.
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.
) 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.
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 Responsibilities: 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 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 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 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 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 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 Qualifications / Requirements: Minimum qualifications: Technical degree or certification in Instrumentation / Industrial Automation or equivalent Preferred Qualifications 1-4 years’ experience in instrumentation calibration and repair in a regulated industry 1-4 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, 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.
Must have knowledge of cGMP compliance.
Ability to read and Understand P&IDs, Standard Operating Procedures (SOPs), Schematics, and have 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 gasses, steam, varying electrical voltages and moving machinery.
Knowledge of and ability to use Computerized Maintenance Management Systems.
Strong interpersonal skills are a must.
Proficiency in both oral and written communications is essential.
Must be detail oriented and demonstrate good record keeping practices.
Demonstrate effective writing skills including preparing technical reports, the revision of various technical documentation and procedures.
Must be knowledgeable about industry standards for instrumentation and electrical The 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 facility Hands on experience performing maintenance and repair activities on instrumentation, automation, and equipment in a regulated industry Knowledge of maintenance and instrumentation strategies and techniques Detail oriented individual with the ability to meet deadlines on several activities simultaneously in a fast paced environment Work with minimal supervision Strong communication, mathematical, organizational and problem solving skills Strong understanding of mechanical and electrical engineering concepts in a manufacturing environment, preferably aseptic or clean manufacturing facility Read and interpret construction, engineering P&IDs, and schematic drawings Use a wide variety of computer applications including Google Doc Applications, Word, PowerPoint, Excel, etc.
Strong focus on client support Thorough knowledge of cGMP and GDP compliance Expert knowledge of instrumentation maintenance and asset management Best Practices in a regulated environment Relocation benefits are not available for this job posting.
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