Harmonics recruitment are currently recruiting for a Senior Validation Engineer. This is a full time, permanent position based in Mayo or remote working is also available for the right candidate.
RESPONSIBILITIES:
- Provide Validation input into engineering projects in accordance with GMP and SOP’s. This will require supporting the Project Engineers or Project manager to ensure the completion of key milestones and the monitoring of documented evidence which verifies that such milestones have been met.
- Act as the PMO contact person and coordinator for equipment, process and computer validation/test activities.
- Develop Master Validation Plans
- Ensure best validation and test practices are employed across the company to maximize effectiveness and minimize non-value-adding work.
- Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems.
- Contribute to the development of FAT/SAT protocols
- Responsible for the introduction of several pieces of equipment across several facilities accommodating both the design and qualification of equipment
- Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.
- Ensure all results and data are correct and follow-up on any gaps or discrepancies.
- Provide guidance and direction in the preparation and execution of validation activities
Requirements
- Third level degree in science or engineering
- A minimum of 5 years’ experience in a validation role the Pharmaceutical industry
- Experience in any or all of the following
- Thermal mapping of controlled temperature units
- Sterilisation validation of autoclaves and SIP
- Sterile manufacturing
- Cleaning validation
- Commissioning, Qualification & Validation of new systems and equipment
- Process Validation in Pharma, BioPharma or Medical Device Industries
- Utility qualification
Key Skills
- Strong documentation bias – you will be managing and documenting the entire validation process. The documentation produced must comply with both internal SOPs and externals regulations.
- Attention to detail – it is vital that validation engineers pay attention to every test result and measurement, noticing when something isn’t quite right.
- Analytical thinking – as well as identifying when there is an issue, part of the role can be to suggest why there might be an issue and potential fixes.
- Enthusiasm for working in a team – validation of equipment systems is a team activity and you will need good verbal and listening skills to share information amongst the team members
- Good written communication skills – report and protocol writing is an essential part of the job.
- Preference for a structured approach to working – your work will impact others in the overall Validation team as there will be many documents that require sharing and signing with multiple team members.
- Time management – there is an overall project timeline that needs to be met.
- Initiative – validation engineers need to be able to think on their feet and come up with new and inventive ways to challenge the processes and fix problems.
- Work alone or as part of a team.
For more information on this position please apply online and a member of the Harmonics team will be in touch
All applicants must be eligible to work in Ireland
