careers / Validation Engineer
We are an Irish company that have devoted the past 30 years to delivering innovative custom automation, build to print and tooling solutions for the world’s most advanced manufacturers. Consecutively chosen as a Best Managed Company in Ireland by Deloitte for the past six years, we are committed to always, always delivering the right solution. We specialise in designing and building bespoke, reliable, complete solutions which automate highly complex production processes. Through deep client collaboration we support our customers on the automation journey as they transition to smart methods of manufacturing that ultimately drive productivity and business efficiencies.
Company: Modular Automation
Location: Shannon, Co Clare
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.
Primary Degree BSc / BEng
3-5 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
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 organise 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 will 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.