ITOT Computer System Compliance and CSV Engineer

3 weeks ago

Hillsboro, United States Genentech, Inc Full time

We Make Medicines 

Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with PhaseI of the development process and continuing through to product maturity, PT makes lifesavingmedicines at 11 locations, with the support of partners from around the world. Information (IT) andAutomation Technology (OT) teams are key in producing and delivering medicine to patients. Theorganization is currently undergoing a transformation towards digitalization, advancing fundamentalelements 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 localimplementation experience as a member of Build and Run Squads. 

In collaboration with IT Business Partners, monitor and improve stakeholder and userexperience 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 Part11,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.

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