Full Description

Job Title: Validation Engineer

Location: Boston, MA (Need Local)

Duration: 24+ Months (Contract)

Interview: Video (2 Rounds)

Visa- USC & GC Only

Job Description

KEY RESPONSIBILITIES

Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Conduct Automation Assessments to ensure compliance with 21 CFR Part 11. Coordinate with vendor personnel to schedule and execute of test plans, if required. Coordinates with the internal stakeholders to safely and effectively schedule CQV activities, whenever required. Effectively works with cross departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality. Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (APS), process performance qualification, material qualifications, etc. Develop cycles for sterilization processes and validate them, if required. Completes Vertex assigned training and ensures that they are 100% compliant 100% of the time. Ensure that all Validation activities align with the current Vertex SOPs, global standards and cGMP guidelines. Supports right-the-first time culture for all documents distributed across the organization. Ensure the VCGT Validation team reputation and partnership is flourished with the cross-functional teams.