• Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
• Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
• Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
• Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
• Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
• Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.
• Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.
• Stay updated with industry trends, regulatory changes, and advancements in computer system validation practices.
• Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems.
• Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation.
• Qualification of manufacturing automation systems (e.g. DeltaV, MES etc.)

• Bachelor's degree in Computer Science, Engineering, or a related field.
• Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• 5+ Years experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
• Familiarity with validation methodologies, including risk-based validation approaches.
• Proficiency in creating and executing validation protocols and documenting validation activities.
• Excellent analytical and problem-solving skills, with attention to detail.
• Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
• Ability to work independently and manage multiple projects simultaneously.
• Knowledge of software development life cycle (SDLC) and change control processes.
• Understanding of data integrity principles and practices.
• Experience in Sterile Drug Product manufacturing and associated equipment / utilities / IT Infrastructure, Enterprise systems.
• Experienced in computer systems validation (CSV) from requirements through release of SCADA / PLC controlled equipment (i.e. filling lines, isolators, Lyophilisers)
• Experienced in computer systems validation (CSV) of Emerson DeltaV.
• Experienced in computer systems validation (CSV) of MES.
• Completion of Electronic Record Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for equipment/utility systems.
• Experienced in the use of paperless validation and test tools such as ValGenesis, Kneat, ALM
  
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