Job Title: Automation Systems Validation Engineer
With a global bio pharmaceutical giant located in Dublin West.
The company has the reputation of being one of the largest integrated biotechnology plants in the world and the scale and complexity of what they do is incredible, supporting among others the following processes;
- Large scale Mammalian Cell Culture
- Protein Purification
- Aseptic / Sterile Manufacturing
- Vaccines Conjugation
Salary - competitive package
- 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
- 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.
- 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.