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Validation Engineer II - CSV and Compliance Support
4625 Northeast Brookwood Parkway Hillsboro, OR 97124 US
Job Description
- Work to support the ITOT System owners in tasks associated with the lifecycle of computer system, ie. maintenance, validation, documentation, testing.
- Create/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT). Systems will fall between Level 2 and 3 of the ISA-95 model.
- Help perform MILE (annual system maintenance) activities for ITOT Systems. For example, create, update, execute, or review installation protocols, test protocols, etc.
- Own Quality Management System records (CAPA, Planned Events, Deviations) and orchestrate completion of activities needed.
- 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.
- 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 system maintenance activities such as Periodic System Audit Trail Review, account audits, etc.
- 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.
- Support on documents management systems (Veeva, Condor, eVal)
- Support the team with administrative tasks, such as document formatting, document routing.
- Collaborate with local and global stakeholders in defining and completing validation and compliance activities.
- Attend Quality Huddle Meetings
- Provide Quality Metrics
- Align with global Validation protocols and policies
Minimum Requirements:
- Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
- Minimum 5 years experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry.
- Knowledge of or experience with the following technical areas is preferred: SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, DeltaV, Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring, software development,
- 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.
- 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 integrity risk assessment concepts.
Pay Rate Range: $60-75/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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