$40/hr to $42/hr (On W2) We are looking for a "Validation Engineer" to join one of our Fortune 500 clients.
Top Skills:
Experience providing quality oversight of software validation activities in a regulated industry (e.g., medical device, pharmaceutical, biotechnology, aerospace, or automotive), with the ability to perform the responsibilities described in the Main Responsibilities section. Working knowledge of SDLC, software/system validation lifecycle, and Quality Management System (QMS) requirements. Knowledge of regulatory requirements and industry standards governing computerized systems and software used in regulated environments. Experience reviewing and approving software validation and lifecycle documentation, including requirements, risk assessments, test protocols, traceability matrices, validation reports, and change control records. Demonstrated attention to detail, with the ability to assess documentation for accuracy, completeness, consistency, traceability, and compliance.
Job Responsibilities:
Responsible for providing independent quality oversight of non-product software systems used in regulated environments, including manufacturing, quality systems, laboratories, service, and business operations. Ensures that software validation, implementation, maintenance, and change activities comply with internal quality system requirements, applicable regulations, and industry standards. Reviews and approves Non-Product Software (NPS) lifecycle deliverables to ensure systems are validated, controlled, and fit for their intended use. Quality Oversight & Compliance Provide independent quality review and approval of Non-Product Software validation and lifecycle deliverables in accordance with internal procedures, applicable regulatory requirements, and industry standards (e.g., GAMP 5, FDA 21 CFR Part 11, 21 CFR Part 820, EU
MDR, ISO
standards). Reviews software development and validation documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Review and approve validation documentation, including: User Requirements Specifications (URS) Risk Assessments Validation Plans Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports, as applicable Traceability Matrices Validation Summary Reports Change Assessments and Periodic Reviews Ensure software and digital tools comply with requirements for electronic records, electronic signatures, data integrity, cybersecurity, and documentation control. Verification & Validation Oversight Review verification and validation strategies, protocols, results, and associated records to ensure completeness, traceability, objective evidence, and compliance with established requirements. Provide quality oversight during design reviews and validation activities to ensure appropriate verification and validation methodologies are applied. Cross-Functional Collaboration Partner with Product Development, Information Technology, Manufacturing/Operations, Engineering, System Owners, and other stakeholders to ensure compliance throughout the Software/System Lifecycle. Provide guidance on quality system requirements, validation expectations, risk-based decision making, and documentation practices. Facilitate resolution of quality and compliance issues related to non-product software systems. Risk Management Oversight Ensure risk-based approaches are consistently applied throughout system implementation, validation, maintenance, and change management activities. Evaluate the impact of software changes on validated state, product quality, patient safety, data integrity, and regulatory compliance.
Education:
B.S. in Computer Science; Software Engineering; Biomedical Engineering or an equivalent combination of education and experience. Minimum 5 years' engineering experience and demonstrated use of quality tools/methodologies. (Med Device experience)
Preferred Experience:
Experience providing Quality Engineering or Quality Assurance oversight for Non-Product Software (NPS) systems throughout their lifecycle. Knowledgeable of
FDA 21 CFR
820.30, Quality System Regulations (QSR), Medical Device Directive, ISO 13485/14971 guidelines and
FDA 21 CFR
Part 11. Experience participating in project reviews, validation reviews, change review boards, audit activities, and quality decision-making processes. Proven ability to influence cross-functional teams and provide objective quality guidance in support of compliant system implementation and maintenance. Preferred (optional): GAMP 5 or Computerized System Validation (CSV) training/certification, ASQ Certified Quality Engineer (CQE), ASQ Certified Software Quality Engineer (CSQE). We are looking for the candidate who are eligible to work with any employers without sponsorship . If you're interested, please click "Apply" button
