Description
Our pharmaceutical clients, based in Hertfordshire, are currently looking for a Computer Systems Validation Engineer/Lead. The Validation Lead will be required for an initial 6 month contract to project manage the GAP assessment, remediation programme compilation and the delivery of the site action plan.The role:
• Lead the validation activities (Computer Systems) on site within the Process Control Systems in a biopharmaceutical manufacturing company.
• Conduct an initial GAP analysis; compile a company remediation plan and management of the delivery of the site action plan.
• Detailed project planning specific to the validation related activities.
• Utilisation of a risk based approach to determine the validation requirements.
• Generation, sign-off & execution of various program & GMP related documents and protocols, including a number of the following: validation master plan, URS, FRS/DS, traceability matrix, test specs, IQ, OQ, Integrated OQ & PQ, relevant summary reports and change controls.
• Configuration specifications generation, detailing the specific configuration of the systems / interfaces.
• Document status tracking, to ensure that all the documents are being controlled accordingly.
• Project change control implementation in accordance with requirements, design and system changes.
• Management of deviations and tracking to closure.
Desired Skills and Experience:
• Degree educated or equivalent experience.
• Must have a minimum of 10 years computer systems validation experience.
• Knowledge of validation of Process Control Systems in a highly regulated Biopharmaceutical environment.
• Previous systems validation experience in a GMP / FDA regulated environment is essential.
• Understanding of Integrated packaging hall control systems (Systech, Antares Vision, Laetus, Seidenader etc.) would be an advantage.
• Strong autonomy, analytical, problem solving and interpersonal skills required.
Please do contact us directly for more information.