About Our Technology Teams
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 trusted companion to technology teams, providing guidance and support when decisions need to be made.
A New Opportunity for a Validation Engineer
We have an exciting opportunity for a skilled validation engineer to join our growing team and work closely 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 position 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:
* Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.).
* Lead and/or support validation projects and activities on site, as directed and as appropriate.
* Prepare validation plans in line with the strategic goals of the client and manage timely and compliant delivery of the plan.
* Commissioning and validation of various new processes, technologies, and new equipment.
* Create, review, and approve various quality documents and test data.
* Manage validation exception events and change control processes.
* Develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements.
* Support and represent the technical quality team in meetings, visits, troubleshooting exercises, and audits.
* Generate validation investigations and implement corrective actions.
* Provide continuous improvement for existing validation procedures.
The Requirements:
To succeed in this role, you will require:
* A Science/Engineering Degree and 3+ years of relevant validation experience in a GMP environment.
* Experience in executing multiple projects and participating on cross-functional project teams.
* Organizational skills for concurrent execution of multiple equipment/instrument, facility, and utility qualifications and projects.
* Excellent initiative, decision-making, and ability to work in a core team environment attaining resolutions.
* Performance and results-driven.
About Us:
Oleson is a technology strategy & transformation practice. We specialize in IT/OT systems in manufacturing operations with a particular strength in regulated life sciences manufacturing.
Our unique approach takes a full system view, 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 offer strategic advice or specific implementation services to deliver successful projects.
Our capabilities can be used selectively to augment the capabilities of your own project delivery team.
We have extensive experience in complex capital projects IT/OT projects in manufacturing operations.
To find out more about what we do, visit our website here .