W2 contract only || Computer System Validation – CSV Engineer

About the role

The Validation Lead will oversee the validation process for a computer system within the pharmaceutical, biotechnology, or medical device industry. This role requires extensive experience in System Development Lifecycle, Computer System Validation, and familiarity with FDA and GxP standards.

Responsibilities

• Lead the development and execution of validation plans and compliance reports
• Collaborate with cross-functional teams to ensure alignment on validation strategies
• Provide guidance on validation strategy and manage project timelines
• Conduct timely reviews and escalations to Technical Quality Management
• Support remote teams and manage multiple projects simultaneously
• Write and review documentation for validation deliverables

Requirements

• Minimum 8+ years of experience in the pharmaceutical, biotechnology, or medical device industry
• 2+ years of experience with System Development Lifecycle
• 3+ years of experience in Computer System Validation
• Experience in FDA and/or Global regulated environments
• Good understanding of GxP standards and Risk-based validation
• Knowledge of FDA guidance and industry standards such as GAMP

Qualifications

• Strong verbal and written communication skills
• Ability to lead and mentor a team
• Ability to work effectively with remote teams and manage multiple projects
• Ability to provide validation guidance and escalate issues to TQ management
• Experience in QA methodologies, including Methodologies, designing, reviewing, and approving User Stories, Test Plans, and Reports
• Experience in creating and reviewing System and UAT test scripts, Test procedures, Traceability Matrix, and Design Specs

Skills

• Expertise in validation processes and regulatory requirements
• Strong leadership and team management skills
• Effective communication and problem-solving abilities
• Proficiency in QA methodologies and documentation creation

Benefits

Hybrid work schedule with 2-3 days onsite per week in Raritan, NJ

Pay

Competitive compensation package

Schedule

Hybrid work schedule with 2-3 days onsite per week in Raritan, NJ