Validation Lead

Position: Validation Lead

Location: Raritan, NJ - Remote is available; Hybrid preferred

Duration: Long-Term Contract

Must Have

• Computer System Validation (CSV) experience
• Validation experience with infrastructure and tools
• Experience with infrastructure technologies such as AWS, Azure, JIRA, ServiceNow, etc.

Job Summary

• Candidates need to have hands-on experience in validating and implementing infrastructure systems and tools, e.g., AWS, Azure, JIRA, ServiceNow, etc.

• Any recent experience with divestiture/separation is a huge plus, including manufacturing site cutovers involving infrastructure and applications.

• Ability to manage multiple dispositions for multiple managers with limited supervision.

• Must have a proven track record of large acquisitions and separations with strong CSV expertise, especially within Acquisition/Divestiture/Separation projects.

• Ability to manage the process end-to-end, from inventory, assessments, and remediations through final dispositions.

• Requires 7-10 years of relevant experience and experience leading/advising both Junior and Senior resources.

• Specifically requires experience within the pharmaceutical, biotechnology, or medical device industry.

• Experience working in an FDA and/or globally regulated environment, with a strong understanding of GxP standards and risk-based validation.

• Ability to define and implement risk-based validation activities.

• Experience writing and executing documentation for all aspects of validation deliverables, including:

• Requirements

• Compliance/Validation Plans

• Test Protocols

• Test Summary Reports

• Compliance/Validation Reports

• SOPs/WIs

• Experience reviewing:

• System Test Scripts

• User Acceptance Testing (UAT) Scripts

• Traceability Matrices

• Design Specifications

• Strong experience with QA methodologies, including designing, reviewing, and approving:

• Test Plans

• System Test Scripts

• UAT Test Scripts

• Test Procedures

• Strong verbal and written communication skills.

• Ability to work effectively as a team player, lead a team, or independently 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.

Key Responsibilities

• Validate and implement infrastructure systems and tools, including AWS, Azure, JIRA, ServiceNow, etc.
• Support divestiture/separation initiatives, including manufacturing site cutovers involving infrastructure and applications.
• Manage multiple dispositions across multiple managers with limited supervision.
• Lead and support large acquisitions and separations, with strong expertise in Computer System Validation (CSV), particularly within Acquisition/Divestiture/Separation environments.
• Manage validation activities end-to-end, from inventory and assessments through remediation and final dispositions.
• Lead and advise Junior and Senior resources.
• Apply validation expertise within pharmaceutical, biotechnology, or medical device environments.
• Work within FDA and/or global regulated environments, ensuring compliance with GxP standards and risk-based validation practices.
• Define and implement risk-based validation activities.
• Write, execute, review, and manage validation documentation, including Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports, SOPs, and WIs.
• Review system test scripts, UAT scripts, traceability matrices, and design specifications.
• Apply QA methodologies and participate in designing, reviewing, and approving Test Plans, system testing, UAT test scripts, and test procedures.
• Provide validation guidance, timely reviews, and appropriate escalations to TQ management.
• Collaborate effectively with remote teams while supporting multiple changes and projects simultaneously.
• Demonstrate strong verbal and written communication skills and the ability to work independently or lead teams as required.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.