Validation Engineer

1 day ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time

On behalf of our client, a global medical devices company, we are currently recruiting for a Validation Engineer. This is a permanent, full-site position based in North Wicklow/South Dublin.

Reports to

Maintenance, Engineering and Validation Manager

Essential responsibilities

  • Compilation and execution of validation protocols
  • Compilation of validation summary reports
  • Collection, test, measurement, data entry, data analysis of samples
  • Software Validation
  • Statistical Analysis (in particular data interpretation, sample sizes)
  • Validation documentation review
  • Be an active contributor to Calibration activities on-site

Qualifications/Experience required:

  • Minimum 3 years industrial experience in a facility manufacturing in pharmaceutical environment, vitro diagnostic products or equivalent
  • Educated to BSc. Level in a science or engineering related discipline or equivalent (preferable)
  • Knowledge of elements of validation documents (VMP / FAT / SAT / IQ / OQ / PQ etc.) (essential).
  • Understanding of production operations, GMP and GLP requirements.
  • Demonstrated strong organisational skills from both administrative and hands-on standpoints
  • Demonstrate a high level of care and attention to all aspects of the role and show a desire to achieve excellence through own initiative
  • Proven to be a team player, capable of working within multiple areas while maximising performance

Familiarity in the use of the following equipment, instrumentation and software would be advantageous:

  • Incubators, Fridges, Freezers, Cold Rooms.
  • Filling, Stoppering, Capping, Labelling, Packing manufacturing lines (fully automated, semi-automatic or manual)
  • Freeze Drying processing equipment
  • Validation of Computerized Systems (FDA regulation)
  • Microsoft Office (Word, Excel, PowerPoint etc.)
  • Statistical Software

Skills and Behaviours

  • The successful applicant will have excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills and be team focused.
  • The successful applicant's professional characteristics will include attention to detail, initiative, ingenuity, creativity, resourcefulness, flexibility and perseverance.
  • The successful applicant will work with a sense of urgency, be able to prioritize appropriately, have excellent organizational skills and have the ability to be impartial and objective.
  • The successful applicant will have a Continuous Improvement mindset, with demonstrated achievements from previous roles.
  • Have a willingness and ability to collaborate with and influence other groups, in a positive, team‑based environment.
  • Have excellent problem solving and troubleshooting skills.
  • Ability to read, analyse, interpret technical data, interpret technical procedures, and governmental regulations.
  • Be an active learner, developer of self, mentor coach and develop others.
  • Ability to prepare PowerPoint presentations and/or effectively present information and respond to questions, within a group setting.

Language Skills:

Fluency in English, both written and oral, is a pre-requisite.

For a full Job Spec and to apply for this role please call Linda on +353 12784671 or e-mail ldunne@thornshaw.com.

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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