If you are interested in pursuing a career in computer software validations in a GMP regulated environment, this is a unique opportunity to progress your career with a leading software company. 

Job Description

We are looking for a Validation Engineer to join our expanding team. the role will be based in the South-east and will involve working in a GMP environment.

The successful candidate must have a Level 7/8 qualification in Computer Science, Quality, Engineering or related discipline and 1-2 years working in a similar role with GMP exposure.

Responsibilities/ Duties:

·       Assist with the preparation of software validation protocols and test scripts in accordance with procedures.

·       Assist with the execution of test scripts and capture test evidence

·       Prepare associated documentation for equipment and systems validations.

·       Work with Quality department to ensure validations are in line with customer validation standards.

·       Create documentation and reports across the entire validation life cycle

The successful candidate will be a vital member of the Validation team working large scale projects for a variety of global Medical Device and Pharmaceutical leaders.

In this role, you will have the opportunity to participate in all aspects of the Validation Life Cycle. You will ensure our software solutions are delivered to the highest quality standards by collaborating with the Software Development team members.

You will be responsible for the validation of software, equipment and automation in accordance with the latest GMP, GAMP and FDA regulations.

You will also be responsible for all validation and change control documentation.

Requirements

The successful candidate must have 

• Level 7/8 qualification in Engineering, Computer Science, Quality or Validation related discipline. (Essential)
• 2 years’ experience in a similar role. (Advantageous)
• Be very meticulous and can work to project deadlines. Excellent communication skills, written and verbal English communication is essential.
• Knowledge and experience of Software Development and Validation Life Cycle would be advantageous.
• Experience of working in a GMP medical device/pharma or similar environment
• GAMP experience is a distinct advantage
• Note that both internal and external training will be provided to the successful candidate on Good Manufacturing Practices, Good Documentation Practices and on the Validation Life Cycle.

Benefits:

Including DC Pension, Illness Benefit, Death in Service, Profit Share Scheme, Flexibility, Career prospects, Training and Development.

Application Method:

If you want to find out more or apply for the position please email your CV to Chloe Murphy at cmurphy@dataworks.ie.