Validation Engineer
Candidates must hold a valid work permit/visa or EU citizenship to be considered.
On behalf of our client based in Shannon, Co Clare they are looking for a Validation Engineer to join their team.
Major Activities
- Effectively working within a multidisciplinary team to Prepare, schedule and execute Commissioning, Qualification and Validation protocols
- Lead Risk assessments for process and equipment as required.
- Develop system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems.
- Execute Commissioning and validation of manufacturing equipment, downstream equipment and processes in addition to supervising and witnessing Validation / Qualification carried out by vendors.
- Develop protocols for validation projects using a risk based approach that meets regulatory requirements and industry practices.
- Review and approve Layout development and review for material and personnel flow compliance.
- Review analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data.
- Investigate deviations, write investigation reports and create summary reports.
- Manage equipment vendors to get vendor qualifications scheduled and executed.
- Promote cGMP and regulatory compliance into assigned projects.
- Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Strong trouble shooting and Safety compliance experience is essential for this role.
Job Background
- BSc/MSc or BEng/MEng in Engineering or related discipline.
- 5 years minimum in validation, quality systems, operations, engineering or any combination thereof.
- Equipment Validation Experience
- Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
- Validation experience using risk based approach guidelines, international regulatory requirements and standards and other in.
- Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
- Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.
Salary level is a very attractive one if you are the right fit and would depend on experience
Candidates must hold a valid work permit/visa or EU citizenship to be considered.
To Apply please click the link.
If this job sounds ideal to you & you want to enquire in complete confidence or make an application click the link or contact Darren Brown in Cpl Limerick on 087 405 3774 or email your details to [email protected]
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