Validation Lead

Sira Consulting, an Inc 5000 company; Raritan (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

Sira Consulting is seeking a seasoned Computer System Validation (CSV) professional in New Jersey to lead validation efforts in a GxP-regulated environment. You will administer retro-validation activities and remediation projects, aligning with FDA and global standards while coordinating with remote teams.

You will write and review validation deliverables, test protocols, and reports, and serve as a validation mentor for the team, ensuring audit readiness and risk-based validation practices.

Qualifications

• 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments.
• Hands-on experience with retro-validation activities and 21 CFR remediation projects.
• 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 validation deliverables (requirements, validation plans, test protocols, test 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

Responsibilities

• Develop, execute, and manage CSV validation deliverables in GxP-regulated settings.
• Lead validation activities and coordinate across cross-functional teams.
• Review and approve test scripts, traceability matrices, and validation reports.
• Provide guidance and timely escalations on validation issues to management.
• Collaborate with remote teams to support multiple projects simultaneously.

Skills

CSV experience

GxP/regulatory

21 CFR Part 11

GAMP 5

Documentation writing

QA methodologies

Team leadership

Communication skills

Remote collaboration

Validation guidance

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