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Validation Team Leader

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Quality & Compliance
  • Date posted: 17/01/2018
  • Job reference: J377408A

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Our client, a leading pharmaceuticals company based in Waterford, has an exciting new opportunity for a Validation Team Leader to join their growing Engineering team.
This role will report directly to the Head of Engineering and will have responsibility for process equipment and utility equipment validation and requalification.


· Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP's and regulatory guidelines.
· Take ownership for quality compliance in all activities you are responsible for.
· Comply at all times with the Health, Safety and Environmental policy and associated procedures.
· Continuously promote a positive safety culture by challenging yourself and others to prioritise safety in everything you do.#
· Ensuring approaches are aligned with current guidelines (ICH/ASTM etc).
· Integrating as far as possible Engineering activity and validation activity.
· Developing procedures and processes which ensure Validation activity is integrated into process design and Engineering execution in new projects and processes.
· Develop the site validation schedule and ensure it is scalable in the event of future additions.
· Develop validation protocols as required ensuring at all times that acceptance criteria is clear and related to process capability.
· Ensure the site change control procedure is integrated into documentation and procedures.
· Manage internal and if necessary external outsourced routine requalification of process equipment.
· Represent the validation strategy and validation results in audits as required.
· Benchmark other industries and organisations to ensure best practice is in use.

Essential criteria:

- A minimum of degree qualified in Engineering or a related discipline,
- At least 5 years' validation engineering experience within a pharma environment (preferably within a sterile manufacturing environment)
- Must have a proven track record in the industry in process validation and the development of procedures and processes to support best practice.

If you are interested in the position, please click 'Apply' below or contact Paul O'Connor on 01 645 5250 for further information.

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