Tap Growth ai · 12 hours ago
Validation Engineer II - CSV and Compliance Support
Hillsboro, OR
Full-time
Onsite
Senior Level
5+ years expTap Growth ai is seeking a skilled Validation Engineer II to provide critical support in Computer System Validation (CSV) and compliance. The role involves developing and executing validation plans, conducting risk assessments, performing audits, and collaborating with cross-functional teams to ensure systems meet industry standards.
Research
Responsibilities
Develop and execute validation plans for computer systems
Conduct risk assessments and ensure compliance with regulations
Perform audits and inspections to maintain quality standards
Collaborate with cross-functional teams to address validation issues
Document validation activities and prepare reports for stakeholders
Provide training on compliance procedures to team members
Qualification
Required
Minimum of 5 years in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry
BS or MS in computer science, engineering, life sciences, or related field
SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, DeltaV, Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring, software development, PLC
Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required
ISA-95 (or IEC 62264); Level 3 (Manufacturing Operations Management): MES, scheduling, quality, and maintenance management.; Level 2 (Batch/Continuous/Discrete Control): Supervisory control (SCADA), PLC monitoring
Knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices
Company
Tap Growth ai
Premium solution for fast growing companies.
Founded in 2022
51-200 employeesFunding
Current Stage
Growth StageCompany data provided by crunchbase