Senior Validation Engineer - Dun Laoghaire
CK Group is recruiting for a Senior Validation Engineer to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis with a rate of up to €64 per hour.
The Company: Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
The Location: This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
The Role: This role holds validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities. The successful candidate will determine validation strategy and approve or reject validation documentation.
- Be an integral quality member of a cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain etc.
- Translates company requirements into the language of the Contract Manufacturing Organisation can make a risk-based decision.
- Validation document author/approver.
- Ensure validated parameters are correctly incorporated in Master Batch Records.
- Regulatory - Aseptic processing system oversight (media fill, autoclave validation, EM) content authorship.
- Validation change control assessment.
- Perform Person in Plant activities as required.
- Prepare inspection playbooks.
- Present on topics during inspection demonstrating appropriate behaviours and knowledge of the subject areas.
Your Background: To succeed in this role you will have significant validation experience at Aseptic Manufacturing or API facilities as well as the ability to influence senior stakeholders and partners. This role will be dealing with different time zones (EU and US) so will require some flexibility in working hours.
For more information or to apply for this position, please contact Natasha on 01246 457739 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46026 in all correspondence.