Senior CSV Analytical Instrument Engineer / Senior Validation Engineer
A well-established consultancy serving the life sciences sector is seeking an experienced Senior Validation Engineer to lead validation efforts for analytical laboratory instruments and computerized systems. This position plays a crucial role in ensuring compliance and operational readiness of critical systems supporting pharmaceutical development and manufacturing.
Key Responsibilities:
Oversee validation of analytical instrumentation and associated computerized systems in accordance with regulatory standards.
Write and execute validation documents, including Validation Plans, URS, IQ/OQ/PQ protocols, traceability matrices, and summary reports.
Conduct testing, document outcomes, manage deviations, and support change control activities.
Work closely with IT teams to resolve system issues and support system configuration efforts.
Perform impact and risk assessments with a clear understanding of system functionality and regulatory classification (direct, indirect, and no impact systems).
Support cross-functional collaboration, including input on system integrations and data flows between laboratory or enterprise systems.
Maintain compliance with all validation documentation and adhere to project timelines.
Lead or support engineering studies for process parameter definition and verification prior to validation.
Ideal Candidate Profile:
Bachelor's degree in engineering, life sciences, or a related field.
Minimum of 4 years experience in validation of lab and computerized systems within GMP-regulated environments.
Strong understanding of 21 CFR Part 11, CSV, and validation best practices.
Demonstrated experience with automated systems and data integration workflows.
Effective communicator with the ability to convey complex requirements to technical and non-technical audiences.
Skilled in Microsoft Office tools and general PC applications.
Detail-oriented, self-motivated, and able to thrive in team-based settings.
Additional Information:
This position is fully on-site in Summit, NJ.
Compensation is determined based on experience, qualifications, location, and market conditions.
The employer provides a competitive benefits package, including health, dental, and vision coverage; short/long-term disability insurance; 401(k) with employer match; PTO and holidays; tuition reimbursement; and more.
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