Validation Engineer

Location: County Wicklow, Ireland

Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new / expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side for a global Pharmaceutical organisation on one of their existing manufacturing facilities in Wicklow. 

Located within 45 minutes of Dublin airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 40 hours.

The Role:

We are looking for a Validation Engineer, ideally with OSD experience, to join this Pharmaceutical company for 12 months. You will play a key role in the Technical Services Function,reporting to the Manager of Project Engineering. 

The ideal candidate will have:

• Experience of QA in a FDA regulated environment is preferred.
• At least 5 years of validation experience.
• Past experience writing, reviewing and executing validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report).
• Experience in risk assessments in relation to validation activities. 

Candidate:
The candidate should have a good understanding and experience of the following key areas:

• Preparation, Review, Execution and Approval of Validation documents and associated deviations/NCRs for computerised systems.   
• Analysis of results of testing and determining acceptability of results against predetermined criteria. 
• Computer Systems Validation. 
• Good understanding of Production Applications (e.g. MES, LIMS) with focus on interfaces  Experience with SAP is a plus. 
• Experience with validating serialisation/aggregation solutions is an advantage.   
• Ensuring compliance with current industry regulations and guidelines relating to validation.
• Technical writing experience. 
• Be flexible with regard to project / tasks assignment. 
• Strong attention to detail and accuracy. 
• Advise and support project team on computer validation activities. 
• Strong interpersonal skills to support relationships with a number of stakeholders. 
• Excellent communicator. 
• Project planning experience a distinct advantage.

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