Position: Validation Specialist - ETQ Reliance / Quality Systems
Location: Remote
Duration: 12+ months
About: VLink, founded in 2006, is a leading global provider of software engineering services with next-gen technologies and best-in-class talent. Our Headquarters are in the U.S, and we have offices in 7+ countries from North America-Europe to APAC, with expansion plans in the Middle East. With over 1,000 employees working globally, VLink has helped SMBs, and large enterprises achieve their business goals, and gained the trust of Fortune-250 companies. VLink is 'Great Place to Work® Certified™' and has been a consistent winner as- Best Places to Work in CT. Trust, collaboration, and accountability are the three elements that are at the core of VLink's work culture. We value our professionals, providing comprehensive benefits and the opportunity for growth.
Position Description: We are seeking an experienced Validation Specialist with deep expertise in ETQ Reliance, Quality Management Systems (QMS), Life Sciences regulations, and computer system validation. The ideal candidate will lead validation activities for quality systems while ensuring compliance with FDA, GxP, and industry standards. This individual will collaborate with Quality, IT, Business stakeholders, and vendors to support the implementation, enhancement, validation, and maintenance of ETQ Reliance and related quality applications utilizing both SDLC and Agile methodologies.
This role can be performed remotely.
Your future duties and responsibilities:
Lead validation efforts for ETQ Reliance implementations, upgrades, enhancements, and integrations.
Develop and execute validation deliverables, including:
- Validation Plans
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Risk Assessments
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Traceability Matrices
- Validation Summary Reports
Ensure compliance with FDA, GxP, 21 CFR Part 11, and applicable regulatory requirements.
Partner with Quality, Manufacturing, and IT teams to define system requirements and validation strategies.
Support configuration, workflow validation, testing, and release management activities within ETQ Reliance.
Conduct risk-based validation assessments and recommend compliance strategies.
Ensure computerized systems remain in a validated state throughout their lifecycle.
Collaborate within Agile project teams, participating in sprint planning, backlog refinement, testing, and release activities.
Support data migration validation and system integration testing activities.
Required qualifications to be successful in this role:
5+ years of Computer System Validation (CSV) experience within Life Sciences, Pharmaceutical, Biotechnology, Medical Device, or regulated environments.
3+ years of hands on ETQ Reliance experience.
Strong expertise in Quality Management Systems (QMS).
Extensive knowledge of:
- FDA Regulations
- GxP Requirements
- 21 CFR Part 11
- Data Integrity Principles
- Computer System Validation Methodologies
Experience developing validation deliverables from requirements through release.
Experience supporting software development projects utilizing SDLC methodologies.
Experience working in Agile and Scrum environments.
Strong understanding of software testing methodologies, defect management, and release processes.
Excellent technical writing, documentation, and communication skills.
Ability to work independently and manage multiple priorities simultaneously.
Required Technical Skills:
- ETQ Reliance Configuration and Validation
- Computer System Validation (CSV)
- Quality Management Systems (QMS)
- FDA Compliance & Requirements
- SDLC Methodologies
- Agile/Scrum Frameworks
- Requirements Management
- Risk Assessments
- Test Script Development & Execution
- Defect Tracking and Resolution
- Audit Readiness and Compliance
Employment Practices:
VLink is an equal opportunity employer committed to fostering an inclusive environment where diversity is celebrated. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Employment is contingent upon successful completion of a background check.
This job application process may use AI-powered tools to assist in screening and evaluating applications based on objective, job-related qualifications. AI is used solely to support the recruitment process and all final hiring decisions are made exclusively by our human recruitment team.
Applicant information will be handled in accordance with VLink's privacy policy.