Validation Engineer

Job Title: Validation Engineer

Location: Boston, MA (Need Local)

Duration: 24+ Months (Contract)

Interview: Video (2 Rounds)

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.