Validation Engineer

2 weeks ago


Cambridge, United States Katalyst HealthCares & Life Sciences Full time

Responsibilities:

Collaborate with stakeholders to gather and define requirements for validation activities

Design and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Perform risk assessments to identify critical and non-critical systems and validate accordingly

Create and maintain validation documentation, such as Validation Plans, User Requirements Specifications (URS), Traceability Matrix, and Validation Summary Reports

Participate in change control processes and ensure compliance with regulatory requirements

Provide technical expertise and guidance to project teams regarding validation requirements and best practices

Perform periodic review and revalidation of systems to ensure continued compliance

Stay up-to-date with industry trends and regulatory changes related to system validation

Authors IT validation documents for hardware and software, manages document review and approval workflows

Performs the analysis of complex business problems and manages business requirements within area of responsibilities

Performs system administration duties as needed to support the setup and validation of GxP hardware and software

Experience gathering business requirements, software testing (UAT, IQOQ), creating and writing SOP's and GXP validation documentation

Experience within CFR Part 11/GxP software qualification

Understanding of data management for gxp systems

Implementing and managing data integrity across lab and enterprise systems

Data resiliency

backup, restore, archive

Audit trails

Performing annual account reviews, periodic reviews

Performing GMP data quality assessments and managing deviations

Managing document review and approval workflows in a global document management system

Working with data archiving and electronic document management systems (in house systems are OpenLab and Veeva Quality Docs)

Performs the analysis of complex business problems and manages business requirements within area of responsibilities.

Performs system administration duties as needed to support the setup and validation of GxP hardware and software

Bachelor's degree in Computer Science, Engineering, or a related field

Strong understanding of GxP regulations and FDA guidelines, including 21 CFR Part 11

Experience in designing and executing validation protocols and documentation

Requirements:

Bachelor's degree in Computer Science, Engineering, or a related field

Minimum 5 years software and hardware validation experience in a GxP regulated environment

Strong understanding of GxP regulations and FDA guidelines

Experience in designing and executing validation protocols

Excellent communication and interpersonal skills

Detail-oriented with strong analytical and problem-solving abilities

Ability to work independently and manage multiple priorities

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