Validation Engineer

4 weeks ago

Dublin, Ireland VALIDATION ASSOCIATES LLC Full time

The ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business. We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing. Our role is to be a companion on the road for technology teams to be able to use as a tool at times when decisions need to be made.

We now have an amazing opportunity for a validation engineer to join our growing team and work on site with our blue-chip multinational clients within the pharmaceutical industry. This role is based out of one of our client sites in Dublin.

Role Description

This is a full-time hybrid role as a Validation Engineer at Oleson. The primary responsibility of the Validation Engineer is to perform day-to-day tasks related to RTL design, debugging, good manufacturing practice (GMP), validation, and functional verification. The role is located in Dublin, with flexibility for some remote work.

Your responsibilities will include but are not limited to:

1. Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.).
2. Lead and/or support validation projects and activities on site, as directed and as appropriate.
3. Prepare validation plans in line with the strategic goals of the client and manage timely and compliant delivery of the plan.
4. Commissioning and validation of various new processes, technologies, and new equipment.
5. Create, review, and approve various quality documents and test data.
6. Manage validation exception events and change control processes.
7. Develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements.
8. Support and represent the technical quality team in meetings, visits, troubleshooting exercises, and audits.
9. Generate validation investigations and implement corrective actions.
10. Provide continuous improvement for existing validation procedures.

The Requirements:

1. Science / Engineering Degree and 3 years plus relevant validation experience in a GMP environment.
2. Experience in executing multiple projects and participating on cross-functional project teams.
3. Organizational skills for concurrent execution of multiple equipment/instrument, facility, and utility qualifications and projects.
4. Excellent initiative, decision-making, and ability to work in a core team environment attaining resolutions.
5. Performance and results-driven.

About us:

Oleson is a technology strategy & transformation practice. We are uniquely focused on IT/OT systems in manufacturing operations with a particular strength in regulated life sciences manufacturing. Our strength is in taking a full system view and understanding the complex relationships between manufacturing operations, business continuity, IT infrastructure, compliance & change control, and system lifecycle planning.

We have developed our own knowledge and process to ensure your IT/OT systems directly drive your business needs. We are ready to provide strategic advice or specific implementation services. To deliver successful projects, you can use our capabilities selectively to augment the capabilities of your own project delivery team. We have a vast amount of experience in complex capital projects IT/OT projects in manufacturing operations.

To find out more about what we do visit our website here – https://oleson.io/

Don’t worry if there isn’t a current opportunity that suits your expertise and interests. Positions arise with us for experienced professionals on an ongoing basis. To register your interest for future roles that arise within our team, please email recruitment@oleson.io.

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