Senior CSV Analytical Instrument Engineer / Senior Validation Engineer

LVI Associates; Summit (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

A well-established consultancy in the life sciences sector seeks a Senior Validation Engineer to lead validation efforts for analytical laboratory instruments and computerized systems. This role ensures compliance and operational readiness, supporting pharmaceutical development and manufacturing. The ideal candidate will have a Bachelor's degree, at least 4 years of experience in GMP-regulated environments, and strong knowledge of validation best practices.

Benefits

Health coverage

Dental coverage

Vision coverage

Short/long-term disability insurance

401(k) with employer match

PTO and holidays

Tuition reimbursement

Qualifications

• Minimum of 4 years experience in validation of lab and computerized systems.
• Strong understanding of 21 CFR Part 11 and CSV.

Responsibilities

• Oversee validation of analytical instrumentation and computerized systems.
• Write and execute validation documents and protocols.
• Conduct testing, manage deviations, and support change control activities.

Skills

Communication

Detail-oriented

Self-motivated

Education

Bachelor's degree in engineering

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

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Direct message the job poster from LVI Associates

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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Automation Machinery Manufacturing

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