ITOT Computer System Compliance and CSV Engineer

 Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? Are you curious to shape a digital manufacturing architecture, ready to advance competitiveness on the market?   

We Make Medicines! 

Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as using new technologies. 

The Position

This position, based in Genentech's Hillsboro, OR facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data.

The IT OT Team in Hillsboro is supporting Hillsboro Technical Operations (HTO) which is the commercial Aseptic filling for Drug Product and launch site for North America and Hillsboro Innovative Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.

Responsibilities of the role:

• Work to support the IT OT Systems and Development teams in tasks associated with the lifecycle of the system, ie. maintenance, validation, documentation, testing

• Update System lifecycle documentation, as the need arises, for ITOT systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT)

• Help perform MILE (system maintenance) activities for ITOT Systems

• Perform system periodic reviews. This entails performing data collection from the deviations database on the past 3 year’s worth of planned and unplanned events, review impact on system’s validated state and draft reports

• Work with Site Business Integration Managers to scope resource needs for projects and site initiatives

• Support IT OT squads in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems

• Support validation activities, generation, approval and execution of validation protocols

• Assist System Owners in the Periodic System Audit Trail Review

• Single Point of Contact (SPOC) for GSP111, Lifecycle Management of GxP Computerized Systems

• Single Point of Contact (SPOC) for CSV v.6, Global IT Computer System Validation

• Work with the System Owners and Business Process Owners for changes to systems to ensure GMP compliance.

• Owning and managing Veeva Quality records: Deviations, Planned Events, and CAPAs

• Support on document management systems (Veeva, Condor, eVal Roche)

• Lead or coordinate technical discussions and vendor negotiations. 

• Through Agile delivery model, provide leadership, technical expertise and local implementation experience as a member of Build and Run Squads. 

• In collaboration with IT Business Partners, monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release.

• Support regulatory audits

Who You Are

Education

• Bachelor’s degree in Computer Engineering, Automation Engineering or similar

• Minimum 6 years of experience in Computer System Validation and Quality Systems

• Minimum 5 years of experience in system and/or network administration, MES Recipe Authoring, or Automation Engineering

• Prefer experience in the life sciences Manufacturing domain

• Prior experience in working closely with IT OT providers/vendors

• Oversight of validation contractors, overseeing, managing and prioritizing their work

Technical Skills

• System & Network Administration

• MES Recipe Authoring and validation experience

• Experience with industrial data and control interfaces, preferably OPC and OPC-UA

• Ability create and execute validation on computerized systems

• Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment.

• Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc. 

• Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles. 

• Entrepreneurial mindset e.g. "automating automation"    

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.