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Job Description

In today’s new world, our health has become our priority. Indeed, the adage ‘your health is your wealth’ has never been so relevant. We all expect the healthcare and life sciences sectors to deliver on that priority. But they can’t do it alone. How can technology organizations like Sogeti Ireland be part of the transformation needed to make this happen?

Responsibilities:

  • Responsible for preparing and executing commissioning, qualification, and validation for new products, processes, equipment and industrial software as well as assisting in maintaining them in a validated state.
  • Supports validation activities in a GMP regulated manufacturing environment. The Validation engineers will prepare, review, and execute commissioning, qualification (IQ, OQ, PQ), and validation (PV and CV) documents for products, facilities, processes, software and equipment.
  • Supports Project Teams in: GMP Impact Assessments, Instrument Criticality Lists, Critical Components Lists, Requirements Traceability matrices, Design Qualification, Vendor documentation checklists, final handover of documents to Operations.
  • Aids in the planning of commissioning, qualification and validation activities and in interfacing with QA, Production Operators, and Engineering.
  • Ability to handle multiple commissioning, qualification, validation priorities based on the needs of the manufacturing area with guidance from management.
  • Participates on and supports validation projects within the manufacturing areas including but not limited to:
  • Validation and implementation of new or transferred manufacturing process and cleaning validations;
  • Design and execute engineering (pre-validation) studies to support validation activities.
  • Assisting in troubleshooting of process issues, process characterization and root cause investigations.
  • Involved in resolving deviations/non-conformances observed during execution of qualification and validation activities.

  • Interacts / assists in GMP audits.

  • Ability to prepare / issue change controls, CAPAs, and investigations.
  • Prepare Final Reports summarizing the results of executed Validation / Qualification studies.

Skills & Requirements

Skills and Requirements

  • Bachelor’s degree in Engineering or related field, or equivalent combination of education and work-related experience, required.
  • Minimum 3-5 years Qualification (IQ, OQ, PQ) / Validation (PV, CV), GXP experience.
  • Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought.
  • Demonstrated troubleshooting and problem solving skills including the use of designed experiments.
  • Ability to handle multiple tasks/projects
  • Good influencing and negotiation skills to accomplish the same goals for internal and external stakeholders according to Project and business need.
  • Understanding engineering disciplines, work package management and work package control.

Contact Person
Niall Bergin

About the company

At Sogeti, we know how to create value with technology- it’s our passion. We work closely with clients and partners to take full advantage of the opportunities of technology. We mobilize expert teams that create custom solutions from existing and emerging technology. Our value is in our approach, characterized by the speed with which we deliver specialist solutions in digital assurance and testing, data & analytics, digital & development, cybersecurity and life sciences.

Disruption is the norm in today’s digital and business environment. How quickly companies respond to change determines their future success – and their ability to realize rapid value from existing and future technology is crucial to this. At Sogeti, we collaborate across a global network to build innovations that push boundaries. But it’s the way we work with clients that sets us apart. Our client model means we can be hands-on from day one, getting to know our customers and their businesses intimately.

We embrace the value of diversity within Sogeti and the entrepreneurial spirit of our people. If you’re looking to join a company with a proven track record of success and that deeply values its people, Sogeti Ireland offers the opportunity for you to grow and advance.

Sogeti Ireland- where people matter and results count.

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Our Location

Dublin

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