The successful candidate will typically be responsible for the following activities (not limited to):
Collaborate with engineering teams and external equipment suppliers to ensure deliverables meet required qualification and compliance standards.
Ensure computerised system validation activities are performed in accordance with applicable procedures and regulatory expectations.
Develop and manage formal change management records for system updates, improvements, or modifications.
Prepare and execute documentation such as user requirement specifications, validation plans, testing protocols, and summary reports for the introduction or modification of regulated systems.
Establish system specifications and operational procedures aligned with recognised industry standards.
Prepare or update risk assessments supporting system operation and compliance requirements.
Maintain traceability documentation linking system requirements through validation and testing activities.
Develop documentation describing system data lifecycle processes where required.
Participate in equipment testing activities at supplier facilities where applicable.
Work collaboratively with project teams to ensure key deliverables and milestones are achieved within planned timelines.
Ensure all work activities comply with applicable procedures, guidelines, and regulatory expectations relevant to controlled operational environments.
Qualifications, Skills & Experience
Required
Degree or equivalent qualification in engineering, computer systems, life sciences, or a related technical discipline, or equivalent industry experience.
Several years of experience working with validation or qualification of regulated computerised systems within a controlled operational environment.
Demonstrated experience supporting the full lifecycle of system validation activities.
Familiarity with regulatory expectations relating to computerised systems, data integrity, and documentation practices.
Experience producing validation documentation packages for the implementation or modification of regulated systems.
Strong written and verbal communication skills.
Strong analytical and problem-solving capabilities.
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