Job Ref: 03113 | Recruiter: Tom Doyle |
Country: Ireland | Location: Dublin |
Job Category: Process, Pharma Life Science, | Salary Range: €Negotiable |
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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