Validation Lead

Nityo Infotech Corporation; United States; Hybrid; USD 120,000 - 150,000; Full time

Job summary

Nityo Infotech Corporation is seeking a Validation Lead in the United States to drive GxP validation efforts for GEN AI-based solutions including LSMV Safety and Pharmacovigilance systems. The role requires managing end-to-end validation activities, mentoring both junior and senior staff, and coordinating with J&J managers across multiple projects in a hybrid environment.

Ideal candidates will have 7-10 years of experience in regulated industries, strong knowledge of FDA/global compliance, and

Qualifications

• 7-10 years of relevant experience in validation within pharmaceutical, biotechnology, or medical device industries.
• Experience in FDA or global regulated environments with GxP standards and risk-based validation.
• Ability to write and execute validation deliverables (requirements, validation plans, test protocols, test reports, SOPs/WIs).
• Ability to supervise and mentor junior and senior resources; lead teams or work independently.

Responsibilities

• Validate GxP GEN AI-based solutions and LSMV Safety and Pharmacovigilance systems.
• Manage end-to-end validation processes including inventory, assessments, remediations, and final dispositions.
• Coordinate with J&J managers across multiple dispositions with limited supervision.
• Define and implement risk-based validation activities in regulated environments.
• Prepare and review validation documentation: requirements, plans, test protocols, test summaries, validation reports, SOPs/WIs.
• Review system test scripts, traceability matrices, and design specifications.
• Communicate clearly, both verbally and in writing, with internal teams and remote partners.
• Collaborate with remote teams and manage multiple projects concurrently.

Skills

GxP validation

Team leadership

Communication

Remote collaboration

Job description

Role - Validation Lead

Location - Raritan, NJ(Hybrid)

Key Responsibilities

• Candidates need to have hands-on experience in validating GxP GEN AI based solutions and LSMV Safety and Pharmacovigilancesystem
• Ability to manage multiple dispositions for multiple J&J Managers with limited supervision.
• Ability to manage end-end from Inventory, assessments, remediations to final dispositions; 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically 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; Define and implement Risk based validation activities.
• 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, SOPs/WIs). 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, systems and 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.