Senior Validation Engineer - Global Engineer

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.

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