Job Description Summary

Job Description

• Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for systems and processes.
• Conduct impact assessments for changes to validated systems and ensure appropriate validation/re-validation through change management.
• Ensure validation deliverables are accurate, complete, and compliant by planning, reviewing, training, and supporting validation efforts across IT applications.
• Identify, assess, and mitigate risks associated with system validation.
• Manage the implementation and maintenance of validated systems, ensuring ongoing compliance.

• Participate in the full system validation lifecycle—from provisioning to retirement—including:
  • Authoring and reviewing validation documentation (e.g., URS, FRS, configuration specs, infrastructure provisioning, data migration plans, test plans, traceability matrices, retirement plans).
  • Reviewing and approving executed test documentation, including defect and deviation management.

• Provide training and support to project teams on validation methodologies, processes, and best practices aligned with regulatory standards and Global Quality Procedures.
• Develop and maintain validation SOPs, best practices, and supporting documentation.
• Recommend and lead corrective and preventive actions (CAPAs) to enhance validation processes.
• Support audits and inspections by regulatory agencies, providing necessary validation documentation and addressing findings.
• Collaborate cross-functionally to drive continuous improvement in validation practices while adhering to QMS procedures and regulatory expectations.
• Independently address complex validation challenges with innovative and practical solutions.

Qualifications & Skills:

• Bachelor's degree in Life Sciences, Engineering, Information Technology, or a related field.
• Experience in IT software development, testing, validation or quality within regulated environments.
• Familiarity with SDLC, Agile methodologies, and validation/testing documentation practices.
• Strong understanding of Computer system validation and regulatory requirements (e.g., FDA, GxP, 21 CFR Part 11, Annex11 and ISO 13485)

• Ability to work independently and manage multiple projects effectively within the timelines.

•  Strong analytical and problem-solving skills, with the ability to identify issues and propose corrective actions.

•  Excellent communication skills, both written and verbal, with the ability to engage with cross-functional teams, QA, and auditors.

Desired Characteristics

• Experience in Quality, Regulatory Affairs, or Software Engineering domains
• In-depth knowledge of FDA, ISO, and EU regulations for medical devices and healthcare (e.g., FDA 21 CFR Part 820/11, ISO 13485, EU Annex 11).
• Experience in regulated industries such as pharmaceuticals, biotech, or medical devices.
• Prior experience as a Validation or Test Consultant.
• Hands-on experience with regulatory inspections (e.g., FDA, EMA, ISO) and audit readiness.

Additional Information

Relocation Assistance Provided: No