Senior Validation Engineer
Job ID: JOB-11557
Senior Validation Engineer
Our client a leading medical device company in Galway is recruiting for a Senior Validation Engineer for their Galway site.
Responsibilities and Duties
- Generate validation documentation including DV, IQ, OQ, PQ protocols and validation reports, and assist in the execution of protocols.
- Design, generate and execute test plans and test protocols, managing and reporting findings and non-conformances.
- Maintain consistency on validation/ qualification approach across projects, ensuring validation documentation is fully compliant with site specific policies/ procedures and regulations, good manufacturing practices and industry regulations.
- Be supportive of, and encouraging of others in the project team, showing flexibility in the delivery of team results.
- Engaging with cross functional teams to deliver process validation objectives in compliance with regulations and procedures.
- Responsibility for delivery of project timelines.
- Ensure all project related issues and deviations are documented and approved.
- Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results. Applies risk assessment techniques in such circumstances.
- Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions.
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- High understanding of Compliance, Validation Practices including the system development life cycle & Regulations.
- Excellent interpersonal, written and verbal communication skills, including ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies etc., in a multi-disciplinary team environment.
- Ability to work as a team player in a consulting environment.
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
Education & Experience
- Third level qualification in Science or Engineering.
- A minimum of 5 years’ experience in a validation role in a pharmaceutical or medical device industry.
- In depth knowledge of relevant laws and regulations associated with the medical device industry (including FDA 21CFR regulations/ CE)
- Competent working knowledge of recognized Quality Management Systems (ISO9001/ ISO13485/ ISO14971/ GMP).
- Working experience of validation computer systems for use in FDA regulated environments.
For further information on this Senior Validation Engineer role in Galway please contact Clara Burke on 086 8168273/ email@example.com
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