Validation Analyst Engineer

Job Summary:

Change Management

Key Responsibilities:

Change Management Support:

• Review

  Change Requests

   (CRs) to assess the impact on validated systems, equipment, or processes.

• Collaborate

   with initiators, system owners, Quality Assurance (QA), and other subject matter experts (SMEs) to define appropriate validation and testing strategies for proposed changes.
• Ensure all necessary documentation (e.g., risk assessments, impact analysis, d) is accurately prepared and complete prior to change implementation.

• Process

   change records through the workflow, ensuring timely execution of tasks and compliance with standard operating procedures (SOPs).
• Maintain and archive change control documentation in the designated Quality Management System (QMS).

Validation Documentation and Execution:

• Assist in the creation, revision, and execution of validation documents, including:
• Validation Plans (VPs)
• Qualification Plan
• Review Test Scripts and Traceability Matrices
• Validation Summary Reports (VSRs)
• Support the execution of testing activities, ensuring adherence to approved processes and Good Documentation Practices (GDP).
• Document and investigate any deviations or non-conformances identified during testing and assist in defining corrective and preventive actions (CAPAs).

Compliance and Quality:

• Perform Periodic Access Reviews working with Product Owners
• Stay current with relevant industry regulations (e.g., FDA, EMA, GxP, 21 CFR Part 11).
• Ensure all validation activities and documentation meet internal company policies and regulatory requirements.
• Provide support during internal and external audits/inspections related to validation and change control documentation.

Qualifications

Education:

• Bachelor's degree in a relevant scientific or engineering discipline (e.g., Biomedical Engineering, Computer Science, Chemistry, or a related field).

Experience:

• 3-4 years of experience in a regulated industry (e.g., Pharmaceutical, Biotechnology, Medical Device).

Skills and Competencies

• Good understanding of

  validation lifecycle

  (e.g., system development life cycle, GxP concepts).
• Understanding of Change Control principles and processes.
• Good written and verbal

  communication skills

   for collaborating with diverse stakeholders.
• Strong attention to

  detail

   and organizational skills to manage documentation effectively.
• Ability to work both independently and as part of a team.
• Proficiency with Google Suite (sheets, Docs etc) or Microsoft Office Suite (Word, Excel, PowerPoint).