The automation systems validation engineer is responsible for the support of the automated systems on site and ensuring the validated state is maintained.
Automation Systems Validation Engineer: Pharmaceuticals: Dublin
The 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 management of personnel, (external or internal) as part of the execution of equipment or facility modification or expansion projects. You will be service 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.
- 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 the Standard Operating Procedures (SOP) for the Maintenance and Operation of the Automated Systems.
- Maintain the validated state of the automated systems.
- Execute and oversee the Automated Systems Validation activities.
- 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 testing documentation
- Provide technical support to partners within Engineering and Operations for automated systems during the life cycle of the equipment.
- Manage the specification, contract negotiation, purchasing, development and installation of projects within budget and corporate guidelines.
- 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.
- Working on site Automation Systems and continuous improvement initiatives using 6 Sigma methodologies.
- Manage and document the Automation activities associated with Annual Product Quality Reviews.
- Any other activities as directed by the Site Automation Lead.
Education and Experience:
- 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.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.