Cpl in partnership with our client are looking to hire a Senior Automation Systems Validation Engineer.
Senior Automation Systems Validation Engineer
Department: Automation Engineering
Position Reports to: Automation Manager
The Senior Automation Systems Validation Engineer is responsible for the support of the automated systems on site and ensuring the validated state is maintained. This includes the providing support to automation engineer to allow in making changes to qualified system in controlled manner for modification or expansion projects
The ideal candidate will be solutions orientated, delivery focused and have the ability to build rapport with key members of the operations and engineering teams. You will support investigations with automation subject matter expertise. You will work closely with process & equipment engineers in specifying and implementing automation changes / fixes / improvement projects.
Site Automation Lead
• Must be solutions orientated, delivery focused and passionate about supporting production.
• Must maintain up to date understanding of Data Integrity requirements and ensure Automation processes and strategies are in alignment.
• Develop and update the Standard Operating Procedures (SOP) for the Maintenance and Operation of the Automated Systems.
• Execute and oversee the Automated Systems Validation activities to maintain the validated state of the automated systems.
• Support department to be audit/inspection ready and participate in audits and regulatory inspections as required.
• Generate documentation and SOPs associated with each of the automated systems.
• Develop and/or approve testing documentation for changes to automation systems.
• Provide technical support to partners within Engineering and Operations for automated systems during the life cycle of the equipment.
• Participate in the development of the Automated System Life cycle documents.
• Support periodic reviews of Automation and Engineering procedures.
• Coordinate and perform Automation System periodic reviews.
• Coordinate Automation Disaster Recovery exercises.
• Support in continuous activities for automation.
• Support in any other activities as directed by the Site Automation Lead.
• Appropriate Engineering Qualification (preferably B.Sc./ B.E. degree in engineering, with particular emphasis in electrical/electronic, mechanical, or chemical discipline)
• 3-5 years of working experience in industry, preferably in a pharmaceutical or relevant GMP manufacturing environment
• Strong knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation.
• Strong knowledge of Data Integrity/ALCOA requirements.
• Experience in regulatory audits.
• Knowledge of validation deliverables associated with each step of the computer system life cycle
• Experience of managing automation& validation type projects an advantage
• Excellent communication and interpersonal skills
• An ability to work independently
• Excellent organizational agility – The ability to persuade and influence people at all levels and develop good working relationships that promote team working
• Analytical and strategic thinking with good business acumen and the ability to think from the customers' perspective.
• This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.
People / Values Non-People leaders
• Demonstrate the values of Courage, Excellence, Equity and Joy
• Adhere to all HR Policies as appropriate
• Proactive engagement with key stakeholders.
• Best practices developed and shared with other teams /sites.
• Best practices actively sought and copied.
• Proactive & effective communication within and across shifts.
• Good attention to detail whilst retaining the ability to see the bigger picture