Senior Validation Engineer - BioPharma - Dublin


Location: Ireland

EUR 80,000 - 100,000

Job Type: Perm

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-2208-30960

Consultant: Karen McHugh






Are you a Senior Validation Engineer with 5+ year’s relevant industry experience in the Biopharma/Pharma sector.?

This is a permanent role base in Dublin

If you have the relevant experience, please forward your CV to karen@jobcontax.com for review or call +353 1 7978720 to discuss.


Senior Validation Engineer - BioPharma - Dublin


Job Description

Our client provides Project Management, Engineering Design, and Resourcing Services to the Life Sciences Sector.

They currently have a requirement for a Senior Validation Engineer to support our PMO team. 

This position will be based in rhe Dublin Engineering office.

The Senior Validation Engineering will be responsible for providing validation leadership on technical projects in various manufacturing facilities. 

Extensive experience in providing pragmatic solutions to allow for on time project delivery and full integration with the clients Quality Systems is essential. 

The position will be a mixture of site and office based, dependant on the project.

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.

Execute Validation Protocols, root cause deviations and generate validation reports. 

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 in the Life Science industry

Experience in any or all of the following:

Clear understanding of applicable regulations for the pharma, BioPharma or Medical Device Industries

Commissioning, Qualification & Validation of new systems and equipment

Thermal mapping of controlled temperature units

Sterilisation validation (Example steam, VHP)

Sterile manufacturing

Cleaning validation

Process Validation in Pharma, BioPharma or Medical Device Industries

Facility/ Utility qualification

Strong documentation skills – you will be managing and documenting the validation process as applicable. 

The documentation produced must comply with both client 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 and oral communication skills – documentation writing is an essential requirement, along with communication with the client3.

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.

Project management – Ensure the assigned projects are delivered on schedule and within budget.


Package

€80k - €100k per annum

Excellent benefits package.


Contact

Karen McHugh is the consultant managing this position.

If you are a Validation Engineer interested in roles based in Dublin, you can contact Karen by e-mail at karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.


JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Validation Engineers in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.


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