Job Description

VALIDATION ENGINEER – Senior Level (Dublin)

Kppm are looking to recruit a Validation Engineer – Senior Level for our client an international Pharmaceutical Manufacturing company’s engineering operations based in South West Dublin.

Candidates with the following experience would be highly desirable:

·       Equipment commissioning and qualification experience and or

·       Sterile qualification experience (media fills, steam purity testing, air classification RQ)

Responsibilities

·       Lead all aspects of Validation programs for the company in order to meet appropriate GMP regulatory and validation requirements. Act as a Subject Matter Expert in area of responsibility.

·       Provide a visual management system that will display a weekly and monthly output in a tier system.

·       Reporting to Senior Manager Capex Portfolio Project Engineering.

·       Develop and improve the process of validating equipment

·       Write procedures and templates and co-ordinate with PM for execution.

·       Plan and perform equipment and product qualifications.

·       Co-ordinate/ perform utilities qualification studies.

·       Co-ordinate/perform sterilisation/sanitisation validations studies.

·       Co-ordinate/perform thermal mapping studies.

·       Co-ordinate/perform transportation/distribution studies.

·       Generate, execute or review Plans / Protocols / Reports / SOPs / WIs associated with commissioning, qualification and validation activities.

·       Maintain qualification and validation files.

·       Participate as Validation Representative on Project Teams.

·       Participate in Change Control Programme.

Education and Experience

·       Suitable candidates must have a Third level honours qualification in Chemistry / Pharmacy / Biology / Engineering or other appropriate discipline (essential).

·       A Minimum of 3 to 5 years’ experience in a quality, production or engineering function in the Pharmaceutical Industry desirable

·       Excellent communication skills.

·       Fast acting – including an ability to quickly understand and evaluate complex issues and make decisions based on the analysis

·       Achieves results while achieving deadlines

This is a Contract FOR Services and the hourly rate is negotiable depending on experience.

For further information please contact:  Tom Doyle at kppm in Dublin:  Phone:  086 8205038  or Email: tom@kppm.ie

or email tom@kppm.ie

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