Job Title: Quality Systems Validation Engineer
Location: Boston, MA (Local candidates only)
Experience: 8+ years
Duration: 24+ Months Contract
Visa Requirement: USC & GC Only
Job Summary:
We are seeking a detail-oriented Quality Systems Validation Engineer to drive and execute validation activities in compliance with cGMP guidelines and internal quality standards. This role involves drafting, implementing, and executing validation protocols while collaborating with cross-functional teams to ensure compliance and quality in all processes.
Key Responsibilities:
Draft and implement Quality System documentation to establish effective validation practices.
Author and execute URS, IQ, OQ, and PQ protocols in compliance with GDP guidelines.
Conduct automation assessments to ensure adherence to 21 CFR Part 11 regulations.
Coordinate with vendors and internal stakeholders to schedule and execute test plans and CQV activities.
Collaborate with departments including Information Services, EH&S, Global Security, Design, and Quality.
Author and support documentation for process validation activities, including aseptic process simulations (APS), process performance qualification, and material qualifications.
Develop and validate sterilization process cycles, as required.
Complete all assigned Vertex training and maintain 100% compliance.
Ensure all validation activities follow Vertex SOPs, global standards, and cGMP guidelines.
Promote a right-first-time culture for document creation and maintain strong partnerships across teams.
Qualifications:
Proven experience in process and system validation in a regulated environment.
Knowledge of cGMP, GDP, and 21 CFR Part 11 requirements.
Strong documentation and protocol authoring skills (URS, IQ, OQ, PQ).
Ability to coordinate cross-functional validation activities.
Local to Boston, MA.
US Citizen or Green Card holder.
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