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 Good Documentation Practices. Proficient in developing lifecycle documents and executing testing protocols while maintaining data integrity and traceability.
Highest-signal resume keywords
Risk-Based ValidationQualification Protocol DevelopmentGxP ComplianceGood Documentation PracticesFDA cGMP Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation PlansRequirements SpecificationsTest ProtocolsTraceability MatricesRisk AssessmentsDiscrepancy RecordsIQ/OQ ProtocolsData Integrity PrinciplesChange ControlCSV Lifecycle Documents
Soft Skills
Strong Written CommunicationStrong Verbal Communication
Industry Keywords
GMP RegulationsEU GMP Annex 121 CFR Part 11ISPE/GAMP PrinciplesPharmaceuticalBiologicsUser Requirements SpecificationsControl NarrativesCalibration RecordsCommissioning Evidence
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 validation plans, requirements, specifications, risk 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 through closure
- Govern system changes and releases through Change Control and ensure validation, procedural, training, data, and operational readiness activities are complete
- Review qualification documents and system records, confirm qualification boundaries, prerequisites, test strategies, acceptance criteria, and documentation needs
- Perform field walkdowns and document reviews
- Generate and route IQ/OQ protocols for approval
- Execute approved IQ/OQ protocols according to company procedures and Good Documentation Practices
- 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 review packages
- Generate and maintain Requirements Traceability Matrices
- Generate 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 industry standards relevant to the assigned scope
- 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 and to execute testing accurately in the applicable field or computerized environment
- Strong written and verbal communication skills in English
- Spanish proficiency is preferred for effective site interaction
Benefits
Comp & perks- Equal opportunity employer
- Supportive, purpose-driven team environment
- Opportunity to shape the future of healthcare and technology
- Approved remote testing may be performed remotely when authorized