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Senior Validation Engineer - Global Engineer

Engineering
Dublin
Peter Paul Galligan
Permanent
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Job Reference: JO-2012-65497_1607092884

Summary:

Senior Validation Professional - Global Engineering



A vacancy exists for a permanent Senior Validation Professional within the Global Engineering Department for my Pharma client based in Dublin; reporting to the Engineering Projects Manager.


You will lead aspects of validation programs for the company in order to meet appropriate GMP regulatory and validation requirements. You will also be a Subject Matter Expert in the area of responsibility.



Roles and Responsibilities include (but are not limited to):


· 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.


· Adhere to Group Validation Policies, Guidelines and the Site Validation Master Plan.


· Keep abreast of / adhere to regulatory requirements in relation to validation areas of responsibility.


· Ensure Project related work is carried out in accordance with the requirements of LEO Group Validation Policies, Guidelines, Site Validation Master Plan and GMP.


· Participate in the Self Inspection programme and External Audits.


· Generate APQR reports in area of responsibility.



Key Skills and Experience:



The ideal candidate must have a third level qualification (NFQ Level 8 or higher) in Chemistry/Pharmacy/Biology/ Engineering or other appropriate disciplines.



Minimum of 3 years relevant experience within quality, production or engineering function in the Pharmaceutical industry.



Behaviours & competencies:


· A positive mindset of Safety First


· A confident team player who can work with a high degree of autonomy.


· Ability to engage and influence key internal stakeholders so that they can deliver on improved performance.


· Ability to make timely decisions at the right level with the right data and support them once made.


· Handle unfamiliar situations and solves problems to deliver results.


· Applies analytical skills and deepened knowledge to interpret data and applies independent judgement to tackle issues.


· Drives projects to completion.


· Communicates and influences decisions in their own area of responsibilities directly.


· A motivated self-starter


· Strong and proactive team player who thrives on working in a fast paced production environment.


· Has a continuous improvement mindset always looking at ways to improve with agility, simplicity and efficiency to the fore.



Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


Fastnet - The Talent Group
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Peter Paul Galligan
Peter Paul Galligan
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