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 services and qualification protocols within GxP environments, with a strong focus on compliance with GMP regulations and Good Documentation Practices. Proficient in developing and executing lifecycle documents and testing protocols while ensuring data integrity and regulatory adherence.
Highest-signal resume keywords
Risk-Based ValidationQualification Protocol DevelopmentGMP Regulations KnowledgeGood Documentation PracticesCSV Lifecycle Experience
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 PlansTest ProtocolsRequirements Traceability MatricesIQ/OQ ProtocolsRisk AssessmentsSupplier AssessmentsData Integrity PrinciplesChange ControlAudit TrailsElectronic Records
Soft Skills
Strong Written CommunicationStrong Verbal Communication
Industry Keywords
GxPFDA cGMPEU GMP Annex 121 CFR Part 11ISPE/GAMP PrinciplesPharmaceuticalBiologicsUser Requirements SpecificationsFunctional SpecificationsCalibration Records
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, architecture, supplier documentation, configuration, 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, roles and permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, time synchronization, backup and recovery, migration, security, and system administration
- Execute approved testing, capture objective evidence, manage incidents and deviations, coordinate corrective actions and retesting, and maintain requirements-to-test traceability
- Govern changes and releases through Change Control and verify validation, procedural, training, data, and operational readiness activities before release
- Review requirements, design documents, manuals, commissioning and calibration records, certificates, risks, and lifecycle documents for assigned systems or equipment
- Confirm qualification boundaries, prerequisites, test strategies, acceptance criteria, and required documentation
- Perform field walkdowns and readiness document reviews
- Generate and maintain IQ/OQ protocols, Requirements Traceability Matrices, and Qualification Summary Reports
- Execute approved IQ/OQ protocols according to company procedures and Good Documentation Practices
- Document discrepancies, exceptions, and deviations; provide technical information for resolution
- Coordinate authorized retesting after corrective actions
- Assemble executed protocols and evidence packages for review and approval
- Support comment resolution and final approval of qualification documentation
- 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 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- People-first, purpose-driven, supportive team culture
- Equal opportunity employment