Validation Engineer II

Intake Notes with HM /Must haves:


Good knowledge of Food and Drug Administration regulations/guidance (or Annex) Effective communicator with excellent verbal and written communication skills - will need to build & maintain good working relationships.


Core responsibilities : -

• Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance.
• Develop plans and reports such as validation plans/reports, test plans/reports (and other deliverables).
• Update existing validation deliverables and procedures in collaboration with the system owners.
• Apply ALCOA+ principles to validation deliverables and quality management system records.
• Support in deviation investigations to identify root causes and define corrective and/or preventative actions.
• Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready.
• Collaborate with local and global stakeholders in defining and completing validation and compliance activities.

Description:

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.


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 ITOT Projects and Compliance Lead. Active involvement in the daily operations for all Manufacturing ITOT systems and infrastructure to support day-to-day operations of the 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 Innovative 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 ITOT systems and infrastructure 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.

Responsibilities of the role:
• Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance.
• Develop plans and reports such as validation plans/reports, test plans/reports (and other deliverables). Update existing validation deliverables and procedures in collaboration with the system owners.
• Apply ALCOA+ principles to validation deliverables and quality management system records.
• Support in deviation investigations to identify root causes and define corrective and/or preventative actions.
• Support system audit/inspection preparation and execution as CSV subject matter expert. Complete or orchestrate timely completion of post-audit action items.
• Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready.
• Support system periodic reviews according to company procedures.
• Collaborate with local and global stakeholders in defining and completing validation and compliance activities.

Role Minimum Requirements
Education
• Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
• Minimum 6+ years experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry.
• Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus.
• Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles.
• Good understanding of system and data risk assessment concepts.

Competencies & Behaviors
• Takes responsibility, drives results, and achieves expected outcomes.
• Effective communicator with excellent verbal and written communication skills.
• Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals.
• Builds trustful and effective relationships.
• Able to think innovatively and translate ideas into actionable plans.
• Ability to work productively with stakeholders from different technical domains and cultures.

Technical skills
• Knowledge of or experience with the following technical areas is a plus: System administration, software development, networking, server administration, MES Systems administration and recipe authoring , Industrial Data and manufacturing controls systems.
• Familiarity with IT Service Management, Quality and Document Management systems such as Veeva, Client ALM, Valgenesis, and ServiceNow, is a plus.
• 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.