Description
Global leading generic and specialty pharmaceutical company based in North Dublin is seeking a Validation Engineer to join their Quality/Validation function within their brand new state of the art manufacturing facility in Dublin.About the Company
The company has a huge presence here in Ireland, having 4 different sites across the country. It is an exciting growth phase for this organisation and there is significant expansion plans for this brand new Dublin manufacturing facility which is home to their brand new Respiratory product line. The scale of expansion and investment is extremely significant. Being part of this organisation at this time will provide you with a sense of achievement and opportunity to really make an impact. You will get great exposure to cutting edge systems and will get to see the product right through to market.
The new Dublin offices been recently fitted with modernly decorated meeting and board rooms and a brand new subsidised canteen which is provides the same food as a popular lunch delicatessen based in Dublin city centre.
- Responsible for execution of Cleaning Cycle Development for process equipment such as Parts-Washers & Blender
- Responsible for assessing worst-case swabbing locations for equipment & generation of acceptance criteria for product & detergent carryover for cleaning validation/verification activities
- Generation and execution of Cleaning Validation Protocols, including co-ordination of activities & sampling
- Co-ordinating cleaning verification activities after equipment cleans- co-ordination of swabbing etc.
- Responsible for developing and executing Validation strategies (Validation Plans, Validation Protocols, Validation Reports), with particular emphasis on Computer Systems Validation in line with current regulatory requirements, corporate policies and site procedures.
- Conducting risk assessments (e.g. Quality Risk Assessments/FMEA) on manufacturing equipment & computer systems
- Executing Computer System Validation Assessments (e.g. 21CFR Part 11 assessments) on new equipment
- Conducting Periodic Reviews for Computer Systems & Equipment
- Generation & execution of PV protocols
Requirements;
Ideally the successful candidate will have 3rd level qualification in a Science/Engineering or related discipline and A minimum of three to five years' experience in a similar role. Specific experience in Cleaning Validation and/or Computer Systems Validation is required.
Package on offer with the Job:
Salary is competitive and Benefits include pension contribution, health-care, bonus, life assurance, subsidized canteen.
Are looking for a new challenge? A start up experience where you can really make an impact? This is the role the role for you! Please apply below with an up to date CV.
No CV? Not Sure Yet? Give me call for more info and an opportunity to ask more questions Anna Mooney !