Validation Lead

We are looking for Validation Lead for our client in Raritan, NJ.

Job Title: Validation Lead

Job Location: Raritan, NJ

Job Type: Contract

Job Overview:

Pay Range: $48hr - $53hr

Requirement/Must Have:

• Experience in the Pharmaceutical, biotechnology, or medical device industry.
• 2+ years experience with System Development Lifecycle.
• 3+ years experience in Computer System Validation.
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance s and industry standards (i.e., GAMP).
• Experience in writing and executing documentation for all aspects of the validation deliverables (e.g., Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports).
• Experience in QA Methodologies, designing, reviewing and approving User Stories, Test Plans and Reports, System and UAT test scripts, Test procedures, Traceability Matrix, and Design Specs.

Responsibilities:

• Lead a team and work with remote teams to support several changes/projects simultaneously.
• Provide Validation guidance, timely reviews, and escalations to management.
• Work with global project teams during the initial project planning phases.
• Provide guidance on validation strategy and handle the highly fluid state of the project.

Skills:

• Strong verbal and written communication skills.
• Ability to lead a team.
• Ability to communicate effectively with stakeholders.