Validation Lead

Raas Infotek; Raritan (NJ); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Raas Infotek is seeking a Validation Lead - CSV with Annex 11 Remediation in Raritan, NJ. Hybrid work model available. The role requires extensive experience in computer system validation (CSV) in GxP environments, including retro-validation and remediation projects.

Responsibilities include writing and executing validation deliverables, reviewing test scripts and traceability matrices, leading QA practices, and coordinating with remote teams to deliver timely compliance across multiple projects.

Qualifications

• 5+ years of CSV experience in GxP environments.
• Hands-on retro-validation and Annex 11 remediation.
• Experience in pharma/biotech/medical device industries.
• Excellent verbal and written communication.
• Ability to lead teams and work with remote groups.

Responsibilities

• Write and execute validation documentation and reports.
• Review system test scripts, UAT, and traceability matrices.
• Lead QA methodologies and validation test plans.
• Coordinate multiple projects and provide timely escalations.
• Collaborate with cross-functional and remote teams.

Skills

CSV experience

GxP regulations

Team leadership

Documentation

Risk-based validation

Communication skills

Remote collaboration

Job description

Job Role: Validation Lead -CSV with Annex 11 Remediation

Location: Raritan, NJ (Hybrid)

Visa: USC/GC/H1B

Job Description:

5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands‑on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.

Experience in the Pharmaceutical, biotechnology, or medical device industry

Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.

Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports

Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.

Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures.

Strong verbal and written communication skills.

Ability to work as a team player, lead a team or accomplish tasks without supervision.

Ability to work with remote teams and support several changes/projects simultaneously.

Ability to provide Validation guidance, timely reviews, and escalations to TQ management

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Thanks

Prashant Bansal

Raas infotek corporation

262 Chapman road, Suite 105A, Newark, DE-19702