FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in risk-based validation and qualification protocols within GxP environments, ensuring compliance with GMP regulations and effective documentation practices. Proficient in executing testing and managing lifecycle documents to support system validation and integrity.
Highest-signal resume keywords
Risk-Based ValidationQualification Protocol DevelopmentGxP ComplianceGMP Regulations KnowledgeStrong Written Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Qualification ProtocolsCSV Lifecycle DocumentsTest ProtocolsRisk AssessmentsTraceability MatricesData Integrity PrinciplesUser Requirements SpecificationsValidation PlansDiscrepancy RecordsAudit Trails
Soft Skills
Strong Verbal CommunicationAttention to Detail
Industry Keywords
GxPFDA cGMPEU GMP Annex 121 CFR Part 11ISPE/GAMPGood Documentation PracticesPharmaceuticalBiologicsRegulatory GuidanceControl Narratives
Tech Stack
Tools & technologiesSDLC
About the role
Key responsibilities & impact- Provide risk-based validation services for Factorian, L7 ESP, and other GxP computerized systems
- Review intended use, GxP impact, system architecture, supplier documentation, configuration, customization, interfaces, data flows, infrastructure dependencies, and existing SDLC evidence
- Define validation approaches and identify gaps
- Develop, revise, execute, and close lifecycle documents, including assessments, validation plans, specifications, risk assessments, supplier assessments, test protocols, traceability matrices, discrepancy records, summary reports, and release documentation
- Evaluate and test controls for access, permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, time synchronization, backup and recovery, migration, security, and administration
- Execute approved testing, capture objective evidence, manage incidents and deviations, coordinate corrective actions and retesting, and maintain traceability
- Ensure changes and releases are governed through Change Control and required validation, procedural, training, data, and operational readiness activities are complete
- Review qualification documents and evidence for assigned systems or equipment
- Confirm qualification boundaries, prerequisites, test strategies, acceptance criteria, and documentation needs
- Perform field walkdowns and document reviews
- Generate, route, execute, and close IQ/OQ protocols
- Document discrepancies, exceptions, and deviations and provide technical information for resolution
- Coordinate authorized retesting after corrective actions
- Assemble executed protocols and supporting evidence into complete packages
- Generate and maintain Requirements Traceability Matrices and Qualification Summary Reports
- Support review comment resolution and final approvals
- Maintain weekly forecasts, deliverable trackers, and time records
Requirements
What you’ll need- Bachelor's degree in Engineering or related field
- Prior hands-on experience developing and executing qualification protocols or CSV lifecycle documents and tests for the specific service area proposed
- Prior experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments
- Working knowledge of applicable GMP regulations, Good Documentation Practices (GDP), regulatory guidance, data integrity principles, risk-based qualification and validation, and relevant industry standards
- Knowledge of FDA cGMP requirements and, as applicable, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles
- Ability to interpret User Requirements Specifications, design documents, drawings, functional specifications, control narratives, vendor documentation, calibration records, and commissioning evidence
- Demonstrated ability to write clear qualification or validation documents and reports
- Ability to execute testing accurately in the applicable field or computerized environment
- Strong written and verbal communication skills in English
- Spanish proficiency preferred for effective site interaction
Benefits
Comp & perks- Equal opportunity employment
- Supportive, purpose-driven team environment
- Opportunity to contribute to healthcare and technology
- Authorized remote work for documentation development and testing