Planet Pharma · 9 hours ago
Validation Engineer II - CSV and Compliance Support
Hillsboro, OR
Full-time
Onsite
Senior Level
$60/hr - $75/hr
5+ years expPlanet Pharma is a company focused on providing comprehensive solutions in the pharmaceutical industry, and they are seeking a Validation Engineer II to support ITOT system owners with the lifecycle of computer systems. The role involves creating and updating validation documentation, performing maintenance activities, and ensuring compliance with GMP standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Qualification
Required
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
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
Preferred
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
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase