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Validation Engineer

4 months ago

Hillsboro, United States Naderi Engineering, Inc. Full time

Description:


Job Description


Onsite in Hillsboro, OR

Contingent IT OT Computer System CSV Support



Mission:

This position, based in Genentech's Hillsboro, Oregon 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 candidate will report to the local IT OT organization, an organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies.


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 Individualized and Cell Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.




What you’ll be working on:

Active involvement in the daily operations for all Manufacturing IT OT systems to support the system owners for all Manufacturing systems and supporting the team in manufacturing site projects and with various administrative tasks and validation activities.

This include activities like:


Work to support the ITOT System owners 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.

Attend coordination meetings with different groups within the organization to keep up with changes to global IT systems that may affect ITOT Systems

Support System Owner squad 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

User account auditing, provisioning, resets and activation for all IT and OT systems

Creating reports for various systems on demand

Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.

Review ServiceNow tickets and either address them or route them to the SME

Support on documents management systems (Veeva, Condor, eVal Roche)

Support the team with administrative tasks


Role Minimum Requirements


Education

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

Minimum 5 years of experience in system and/or network administration



Competencies


Management skills

Attention to details and good problem-solving skills

Demonstrated ability to think and solve problems at a system-level

Ability to work and interact productively with stakeholders from different technical domains

Ability to multi-task with a calm behavior and work under pressure in a fast-paced environment

Good team player, self-confident, motivated, and independent

Good communication skills



Technical skills

System Administration

Network Administration

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

System administration, supporting multiple platforms and applications

Ability create and execute validation on computerized systems

Biopharmaceutical or similar Manufacturing domain knowledge.

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.

  1. Entrepreneurial mindset e.g. "automating automation"