The Position

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 arepassionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world. The Controls Engineer position is part of Genentech’s’ ITOT team at the Hillsboro Individualized Therapy (HIT) facility based in Hillsboro, Oregon. HIT is a next generation cell and gene therapy facility with multiple technologies for delivering individualized therapies. In this integral role, you will be part of a dedicated cross-functional team responsible for providing control system automation and system level engineering capabilities and expertise for existing and future equipment including generating and executing qualification protocols. Focus on providing long-term support for existing facilities with respect to the automation control systems for process, utility and building systems. Lead automation impacting projects with small and/or focused scope and provide input into strategic initiatives. The ability to collaborate is crucial, and success in the role will require the individual to thrive in a team environment and not act solely as an individual contributor.

Job Responsibilities
Essential

• Perform automation control (PLC/HMI) engineering services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement. Automation lead for equipment/software FAT, field testing and commissioning

• Produce and review design drawings and specification documents (URS, FS, DS, etc.).

• Generate, execute, and review design testing, generate and participate in functional specification testing, and perform field inspection services.

• Generate, execute, and review Installation and Operational Qualification protocols.

• Generate, review, and approve GMP Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.) in electronic document management systems.

• Initiate, execute, and track progress of change records.

• Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget

• Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.

• Support plant operations to assess discrepant events and changes for automation impact

• deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings.

• Adhere to site SOPs and WIs for daily and project deliverables and drive improvements to business processes.

• Attendance and participation in department and staff meetings

• Maintain training qualifications.

• Interact with vendors ensure systems meet site requirements

• Manage contractor staff, track project deliverables, and provide status updates to project team.

• Fosters a positive safety culture in which no one gets hurt.

• Provide diagnostic troubleshooting assistance as required, including off-hour support.

Education and Experience

• Minimum of 8 years applicable automation and/or instrument and control system experience.

• Pharmaceutical/biotech industry/GMP experience a plus.

Knowledge, Skills and Abilities

• Proficient knowledge of Rockwell (Local PLC/HMI and SCADA) managing interfaces to external systems including OPC Servers, interfaces to SAP and associated programming languages

• A demonstrated ability to apply automation solutions and troubleshoot complex problems on highly automated equipment to address business needs

• Demonstrate good organizational and time utilization skills.

• Experience with Biopharmaceutical manufacturing, design or/and construction.

• Knowledge of process, utility and building control systems.

• Knowledge of GMP guidelines, experience in generation of controlled documents.

• Qualification experience related to control and computer systems.

• Knowledge of ISA standards, P&IDs and practices for instrumentation.

• Knowledge of PID control theories and techniques.

• Ability to create and interpret electrical schematics and P&ID drawings

• Demonstrate good interpersonal skills with an ability to interact well with a variety of

• Personalities, discipline skills and educational levels.

• Demonstrate good written and verbal communication skills.

• Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.

• Demonstrate strong working knowledge of PC based programs and web based systems.

• Ability to work independently with no direct supervision.

Work Environment/Physical Demands/Safety Considerations

• Work in a standard office environment.

• May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots. No make-up or jewelry can be worn when working in the

• clean room environment.

• May work with hazardous materials and chemicals.

Relocation benefits are not available for this job posting.

PLEASE NOTE: We recognize that some candidates will consider applying for these roles only if they meet all required and preferred qualifications. Others will apply simply if they believe they generally fit the profile of someone in this role. We are eager to have a diverse pool of candidates and we are eager to be challenged to find new and better ways of doing the work that we do. If you believe you are qualified to do the work we have described here, and if you are excited about the work, we encourage you to apply even if you are not sure you meet every qualification. Thank you

Roche is dedicated to ensuring fair and transparent pay practices for its employees. In compliance with state legal requirements, you may notice some of our job postings will now list salary ranges. Please note that the broad ranges are aligned with our global grading framework and, in some cases, may also include geographic differentials.

Roche is an equal opportunity employer.

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.