Validation Specialist GA
2 weeks ago
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Specialist
Approximate Start Date: February 2026
Approximate Duration: 4 months to 1 Year
Commitment: Full-time, On-site
Position Overview
We are seeking a Validation Specialist with strong CQV experience, preferably within medical device manufacturing. This is a client-facing, hands-on role that requires technical depth, independent work, and effective collaboration with cross-functional teams. The role focuses on general equipment qualification activities supporting the site platforms.
Key Responsibilities
- Develop and execute validation deliverables including URS, ERES assessments, FAT/SAT protocols, IQ/OQ/PQ, POQ, and traceability matrices.
- Plan, manage, and perform equipment qualification and process validation activities following a risk-based CQV approach.
- Support qualification of general production and laboratory equipment used in medical device manufacturing.
- Apply risk management practices including functional risk documents, assessments, and pFMEAs.
- Execute and manage computerized system validation activities (PLC, HMI, Part 11 requirements, and integration testing).
- Prepare high-quality validation documentation, circulate for review, and incorporate feedback to ensure right-first-time submissions.
- Investigate deviations during execution and manage resolution and documentation of root cause and corrective actions.
- Track documentation cycles, deviations, deliverable status, and project progress versus schedule.
- Communicate effectively with internal and client teams and escalate challenges that may affect schedule or deliverables.
- Provide status updates as required.
- Bachelor's degree in Engineering or Natural Sciences.
- 3 to five 5 hands-on validation experience, including writing and executing protocols.
- Experience with equipment qualification, process validation, and computerized system validation.
- Strong understanding of 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and risk-based validation practices.
- Proficiency in Microsoft Word, Excel, and Project.
- Strong documentation skills, attention to detail, and ability to work independently.
- Effective communication and collaboration skills.
- Experience with Kneat.
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