Description
A rapidly growing & expanding Medical Device company in Dublin are seeking a Validation Engineer & QA Engineer to join them on 1 year contracts with a strong potential for extension.The company are a leading manufacturer within their speciality area & the level of growth in the previous year as well as the growth predicted for next year means this is a very exciting time to join this organisation!
Both the Validation Engineer & QA Engineer will sit within the NPI teams & will start immediately although candidates on notice periods of up to 1 month will be considered.
Rates are approximately €46 per hour as this is a long term contract likely to continue past 18 months - 2 years (unless you choose to go permanent). If you are really interested in this role & have all the experience required but your rate is slightly higher than this, please still apply as there may be room for negotiation .
If you are open to taking a permanent role at the end of the 1 year contract, this will also be on offer.
Full job specifications will be provided on application, please see requirements for the roles below:
Validation Engineer requirements:
- Degree educated or qualification in Engineering discipline
- Strong Validation experience in an NPI (New Product Introduction) environment (NPI experience is a must)
- Strong experience in a highly regulated manufacturing environment, ideally Pharmaceutical or Medical Device but other regulated industries will be considered such as Food or Automotive
- Strong in writing and approving documentation including IQ/OQ/PQ
- CSV experience is greatly advantageous
- Injection moulding experience is greatly advantageous
- Qualification in Engineering/Quality/Science
- Strong QMS experience including ISO 9001/ISO 13485
- Strong in writing and approving documentation including IQ/OQ/PQ
- Generating SOP documents
- Experience as a QA engineer in a NPI environment ideally within Pharma/Medical Devices (or other highly regulated industry as mentioned above)
- Knowledge of validation and change control management
- Knowledge of 21 CFR part 820 & EU GMP is advantageous