Validation Lead

Location: Raritan, NJ (Hybrid)

Pay

$50 per hour (W2)

Skills

• Validation experience with infrastructure and tools (e.g., AWS, Azure, JIRA, ServiceNow)
• Strong CSV expertise, especially in acquisition/divestiture/separation contexts
• Knowledge of GxP standards and risk‑based validation
• Proficiency in writing and executing validation documentation (requirements, validation plans, test protocols, test summary reports, SOPs/WIs)
• Experience reviewing system test and user acceptance test scripts, traceability matrices, and design specifications
• Familiarity with QA methodologies and approval of test plans and procedures
• Strong verbal and written communication skills
• Ability to lead or work independently with remote teams

Responsibilities

• Validate and implement infrastructure systems and tools such as AWS, Azure, JIRA, and ServiceNow
• Manage multiple dispositions for pharmaceutical managers with limited supervision
• Lead end‑to‑end activities from inventory, assessments, and remediations to final dispositions
• Provide validation guidance, timely reviews, and escalations to TQ management
• Support several changes/projects simultaneously across remote teams
• Advise junior and senior resources on acquisition, divestiture, and separation projects
• Define and implement risk‑based validation activities in a regulated environment
• Review and approve system test, user acceptance test scripts, traceability matrices, and design specifications

Qualifications

• 7–10 years of relevant experience in the pharmaceutical, biotechnology, or medical device industry
• Recent experience with divestiture/separation projects, such as manufacturing site cutovers
• Proven track record of large acquisitions and separations
• Experience in FDA‑regulated or global regulated environments with strong understanding of GxP standards
• Demonstrated ability to lead and advise both junior and senior team members
• Experience writing validation deliverables: requirements, compliance/validation plans, test protocols, test summary reports, compliance/validation reports, SOPs/WIs
• Experience reviewing system test and UAT scripts, traceability matrices, and design specifications
• Strong communication and teamwork skills; ability to work independently

Benefits

• Competitive compensation package
• Option to elect healthcare insurance (dental, medical, vision)
• Major holidays
• Paid sick leave as per state law