SeniorValidation Engineer - Lovely SME
I am delighted to be assisting this lovely SME manufacturer in Shannon find a Validation Engineer to join their team and it is a fabulous place to work. They really know how to look after their staff. They have all of the state of the art equipment and work with leading medical device multinationals. They have over 140 staff with very low turnover and I can see why!
It is an exciting opportunity for an experienced Validation Engineer to join their 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.
Excellent Package on offer
- 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 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.
For more infomation call Teresa on 086 025 9348