- Entrepreneurial mindset e.g. "automating automation"
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Validation Engineer
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Validation Engineer
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Validation Engineer
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Test & Validation Engineering, Manager
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Firmware Validation Engineer
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Firmware Validation Engineer
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UST Inc Hillsboro, United StatesWho we are: · At UST, we help the worlds best organizations grow and succeed through transformation. Bringing together the right talent, tools, and ideas, we work with our client to co-create lasting change. Together, with over 30,000 employees in 25 countries, we build for boun ...
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Firmware Validation Engineer
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UST Inc Hillsboro, United StatesWho we are: · At UST, we help the world's best organizations grow and succeed through transformation. Bringing together the right talent, tools, and ideas, we work with our client to co-create lasting change. Together, with over 30,000 employees in 25 countries, we build for boun ...
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Quality Validation Engineer II/Senior
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Computer System CSV Support
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Genentech, Inc Hillsboro, United States Full timeHillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, which combine to produ ...
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Computer System CSV Support
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Computer Systems Validation
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Manufacturing System Engineer
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Computer System CSV Support
3 weeks ago
BEPC Inc. - Business Excellence Professional Consulting Hillsboro, United StatesBEPC has an open position for a Computer System CSV Support in Hillsboro, OR · Contract W2 Period: 16-month contract with possibilities for extensions · Pay & Benefits: $77-$94/hr. + Medical, Dental, Vision and Life Insurance · The IT OT Team in Hillsboro is supporting Hillsboro ...
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Computer Systems Engineer
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MindSource Hillsboro, United StatesJob Title: Computer System Engineer · Location: Hillsboro, OR (Onsite) · Duration: 4 months contract with possible of extension · This position, based in Genentech's Hillsboro, Oregon facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug ...
Validation Engineer - Hillsboro, United States - Naderi Engineering, Inc
3 weeks ago
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 youll 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 years worth of planned and unplanned events, review impact on systems 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 Bachelors 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.
