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My Client is an award winning US Biopharma Company and they are expanding their facility in the West of Ireland into a multi-million dollar state of the art biologics plant in Sligo. It is a very exciting time to be joining, they are currently in growth phase and have invested heavily into this site.They are currently putting in place a highly technical, progressive team who will bring this expansion to reality.

As part of this start-up project, they are now recruiting an experienced Validation Lead who will be responsible for coordinating and implementing the site Validation Program.

You will be given the opportunity to make this role your own and put your own stamp on it. You will build and lead your own team, providing guidance and support to this highly engaged team of technical experts, empowering them whilst also driving results

  • Permanent position with excellent salary and full benefits package.
  • Excellent career development opportunities with this company!
  • Flexitime available for a healthy work, life, balance!

  • Cultural Fit
    There are genuinely a great company to work for and have a very low turn over of staff. Even though they are a major multinational and household name, the site has a lovely ''family feel''. Cultural fit for them is so important. They will always hire the candidate who is down to earth, personable, energetic and positive as well as being ambitious, self-motivated and a team player. They encourage ''outside the box'' thinking with new ideas always welcome. They also promote internally where at all possible. This client really does look after their staff and have consistently won various awards year on year which reflect this and their vision.

    The successful candidate will be degree qualified with minimum 5 years' validation experience in the Biopharma/Pharmaceutical industry. A proven leader with excellent communication and interpersonal skills and a passion for making a difference in people lives.

    Key Responsibilities:

  • Lead, mentor and coach a highly technical team of professionals.
  • Management of validation change control process.
  • Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with Company policies, FDA, European cGMP and GAMP standards.
  • Generation/maintenance of the Validation Master Plans, Project Validation Plans.
  • Generation of validation protocols and final reports to cGMP standard.
  • Review / approval of all protocols and final reports.
  • Ensure all Computerized systems are qualified in compliance
    with Data Integrity policies and regulatory requirements.

  • You will have

  • Relevant Degree qualification in engineering or scientific discipline.
  • Minimum of 5 years experience in a similar role within a cGMP Pharma/Biopharma environment with validation activities demonstrated successfully.
  • Proven People Management and leadership experience
  • Excellent communication and problem solving skills

  • If you are excited at the prospect of progressing your career to the next level and being part of an exciting biologics start-up in Sligo, then I would love to speak with you!

    Next Steps:
    Click Apply!

    For more information and to review the full job spec and scope of this exciting Leadership opportunity, please email your CV and/or contact me on my mobile. I would be delighted to speak with you and guide you through the whole process!

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