||Mayo, Sligo, Galway
||Third Level Degree
Our client GSK based in Sligo, are looking to recruit multiple Validation Engineers for contract and permanent positions. These positions are based in a number of different sites in Ireland.
- Responsible for generation of validation protocols and reports to support Equipment Qualification, Process Validation and Cleaning Validation Studies.
- Execution of these Protocols with assistance from Value Stream Operators and Site Engineers.
- Ensuring that all Protocols and Reports are written to align with Site Procedures and GMP Guidelines.
- Development and Validation of Analytical Methods to support new Validation Activities.
- Adherence to Validation Schedule and escalation of issues relating to Validation Activities to the Validation Lead.
Interpersonal & Communication Skills
- Generate Validation Protocols and reports in alignment with GMP and Site Procedures for Equipment Qualification, Process Validation and where applicable Cleaning Validation Activities.
- Execution of Validation Protocols for Cleaning, Process and Equipment Qualification.
- Addressing, trouble shooting and resolving inspection issues as they occur in relation to validation testing, addressing exception documentation, performing investigations and identification of root cause.
- Identifying and progressing updates in Value Stream Documentation, including Sops, Training Documentation, Methods, etc in support of Validation Activities.
- Strict adherence to Validation Schedules and timely escalation of issues.
- Level 8 Engineering Degree or similar qualification.
- Minimum 3 years Validation Experience in a similar environment.
- Possesses a thorough understanding and experience of Validation principles with good knowledge of GAMP 5 and Industry Standards.
- Obtained experience in risk assessments in relation to Validation activities.
- Working knowledge of computer packages (Word, Excel, Outlook, etc).
- Experience and knowledge of Pharmaceutical/ Medical Devices /GMP Environment.
- High level of accuracy and attention to detail.
- Experience of working in a team environment.
- Ability to prioritise and manage multiple tasks effectively.
- Ability to convey information clearly and accurately.
- Understanding of the relevant quality standards.
- Ability to see the bigger picture and understand impact across the organisation.
For more information please call me on 091 507507 or Annemarie.firstname.lastname@example.org