Careers

Validation Engineer

Company Background

Leaning on decades of experience, we are committed to always, always delivering the right solution. We specialize in designing and building bespoke, reliable, complete solutions which automate highly complex manufacturing processes. Our 160+ accomplished and determined engineers collaborate closely with our customers, supporting them on the automation journey as they invest in smart methods of manufacturing that drive productivity and business efficiencies.

The Role

Exciting opportunity for an experienced validation engineer to join our growing business.    You will implement and manage the creation, revision and delivery of GAMP documentation to FDA regulated companies in accordance with approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.

Qualifications

  • Primary Degree BSc / BEng
  • 3+ years’ experience in a validation role in either Medical Device or Pharmaceutical Industry.
  • Knowledge of Computer System Validation including GAMP 5, 21 CFR Part 11 and cGMP requirements

Responsibilities:

  • Reporting to the Department Manager you generate validation documentation including risk assessments, traceability matrix and validation plan/reports.
  • Development and review of software validation test protocols including FAT & SAT protocols.
  • Participate in FAT and SAT protocol execution, as necessary.
  • Collate and organize all qualification files for the project (including Test protocols, Reports etc.)
  • Document, Investigate and report all deviations/exceptions during the qualification activities.
  • Co-ordinate qualification activities with contractors and vendors as required.
  • Efficient management of priorities
  • Travel may be required

 

Key Skills & Attributes

  • Proven track record in developing validation document for the pharmaceutical and medical device industry
  • Proactive and solutions focused with good organisational skills
  • Ability to multitask and manage multiple projects simultaneously.
  • Excellent communication skills
  • Excellent technical skills including proficiency in Word, Excel, PowerPoint & MS Project.

Submit Your CV

If you don’t see a match for your talents among our current open positions, please do still email your CV with a cover note to be considered for future opportunities.

 
Email: hr@modularauto.ie