Automated Systems Validation Engineer
- Dublin
- Contract
- CAPEX Projects
This vacancy has now expired
Do you want to work with an exciting company who are an established market leader within their niche field? We have a fantastic opportunity for an Automated Systems Validation Engineer to work at one of their sites based in Ireland.
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.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- 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.
Requirements:
- Appropriate Engineering Qualification (preferably B.Sc./ B.E. degree in engineering, with particular emphasis in electrical/electronic, mechanical, or chemical discipline)
- 3 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 projects an advantage
- Excellent communication and interpersonal skills
- An ability to work independently
If this sounds like the position for you then please apply today!
#LI-BP1
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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