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Validation Engineer- Medical Device
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Collabera
San Diego, CA (In Person)
$67,748 Salary, Full-Time
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Job Description
Validation Engineer- Medical Device at Collabera Validation Engineer- Medical Device at Collabera in San Diego, California Posted in 1 day ago.
Type:
full-timeJob Description:
Job Summary:
A leading healthcare technology organization is seeking a Validation Engineer III to support validation and quality system activities within a regulated manufacturing and development environment. This role will be responsible for executing and documenting validation activities, supporting compliance initiatives, and ensuring adherence to applicable regulatory and quality standards. The ideal candidate will possess strong technical writing skills and extensive experience with equipment, process, facility, and computerized system validation.Key Responsibilities:
- Author and maintain validation documentation including protocols, reports, investigations, deviations, CAPAs, change controls, and procedures
- Perform risk assessments and determine validation requirements for equipment, systems, facilities, utilities, and processes
- Generate and execute validation documentation including URS, FRS, DRS, DQ, IQ, OQ, PQ, PV, FAT, and engineering studies
- Develop and revise validation master plans, standard operating procedures, execution plans, and qualification protocols
- Execute validation activities including equipment qualification, process validation, facility qualification, and computerized system validation
- Conduct investigations, resolve deviations, analyze validation data, and prepare technical reports
- Perform and support thermal mapping activities for laboratories, warehouses, refrigerators, freezers, and environmental chambers
- Ensure validation documentation complies with Good Documentation Practices and applicable regulatory standards
- Maintain site validation schedules and support the execution of periodic qualification and validation activities
- Evaluate changes and assess validation impact to determine requalification or revalidation requirements
- Support continuous improvement initiatives within the Quality Management System
- Participate in internal and external audits and provide validation-related support
- Manage validation metrics and documentation within electronic quality management systems
- Coordinate multiple validation projects and communicate project status to stakeholders
- Train cross-functional teams on validation processes and procedures
Required Qualifications:
- Bachelor's degree in Engineering, Biology, Chemistry, or a related scientific discipline
- Minimum of five years of validation experience within the medical device, diagnostics, pharmaceutical, or regulated life sciences industry
- Strong experience performing equipment qualification, facility qualification, laboratory qualification, and process validation activities
- Experience with IQ, OQ, PQ, process validation, spreadsheet validation, and computerized system validation
- Strong knowledge of Design Controls, Good Documentation Practices, and current Good Manufacturing Practices
- Experience applying FDA regulations and industry standards including
FDA 21 CFR
Part 11, FDA 21 CFR Part 820, ISO 13485, andISO 14971
- Strong technical writing and documentation skills
- Proficiency with Microsoft Excel and Microsoft Word
- Experience performing root cause investigations and risk assessments
- Excellent communication, organization, and problem-solving skills
Preferred Qualifications:
- Experience validating diagnostic laboratory equipment including PCR systems, incubators, refrigerators, freezers, and environmental chambers
- Experience performing thermal mapping studies
- Experience supporting regulatory inspections and quality audits
- Experience within a multi-site development or manufacturing environment
- Knowledge of Lean Six Sigma methodologies
- Experience with GAMP5 and Computer Software Assurance principles
- Experience using quality and maintenance management systems
- Familiarity with Agile project environments