- Reference: CJ43962x
- Job Type: Permanent
- Location: Munster, Tipperary
- Category: Science, Pharmaceutical & Food
Responsible for the design and execution of validation documents, programs and strategies to support the implementation of the Validation Master Plans at the company’s facility. Assist in execution of validation and qualification activities. Work with production teams to give guidance and assistance regarding documentation and requirements for test method validation, process validation, facility, utility and equipment qualification, software validation, raw material and commodity qualification.
- The execution and completion of test, software, process, systems and equipment validations and revalidations in accordance with Validation Master Plans.
- Reviews or develops processing and/or manufacturing instructions.
- Maintains detailed documentation through all phases of development, testing and analysis within the company’s tracking databases and systems.
- Work with cross functional groups to improve lean efficiency’s and validation timeline efficiency’s and reduction in production downtime.
- Represent the group in production meetings and cross site meetings.
- Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements
- Performs tests, analyzes data and writes reports and has an ability to work from schematics, engineering drawings, and written or verbal instructions.
- Monitor the progress of validation projects on a daily/weekly basis ensuring that there is continuous drive/focus on meeting schedules.
- Performs routine and some non-routine technical assignments using standard methods and sequences. Assignments require limited judgment in troubleshooting proven processes.
- Work with quality, manufacturing engineering and operations, providing improvement feedback and assisting with resolution of quality and manufacturing issues.
Qualifications and Experience
- Level 7 technical qualification in electronic engineering or related discipline
- The candidate should have a good knowledge in validation documentation with proven problem solving abilities. The ideal candidate would have previous knowledge in regulated documentation lifecycle environment and have experience in electrical testing of electronic and mechanical devices;
- Strong C, C++ and Labview experience is desireable
- Electronic and sortware validation experience
For a confidential discussion and more information on the role, please contact Karen Collins on 021 4911064 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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