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Validation Engineer

  • Job reference: 935964
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 10/06/2021

Orion Group Life Sciences have an exciting opportunity for a Validation Engineer for our Multinational Biopharmaceutical client in Cork on an initial 11 month contract.

The Validation Engineer/ Technical Specialist will be required to collaborate and facilitate running of activities (PPQ batch manufacture, validation activities, investigations, change control) in the Vaccine IPT to ensure the effective and efficient on-time delivery of these activities for the Vaccine IPT.

This requires the delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.

Duties

  • Ensure the highest Quality, Compliance and Safety standards primarily not only with Technical/Validation activities but relating to all activities to enable the team's performance in the Vaccine Technical group within the Vaccine IPT
  • Project validation support including conducting equipment performance qualifications (cleaning and sterilization validation periodic reviews, re-qualifications, temperature mapping)
  • Authoring project validation master plans, SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data.
  • Resolving technical issues encountered during study execution. Lead and close process related deviations and reports and participate in problem solving teams across all areas of the Vaccine IPT (e.g. reliability, Safety, Quality (e.g. CAPA/DN/MDNs etc).
  • This individual will be required to work in a cross-functional team and independently to accomplish validation project objectives.
  • Experience with audits and preparation for audits
  • Works with moderate work direction and is skilled and knowledgeable to the position.
  • Responsible for the technical support of manufacture in the Vaccine IPT.
  • Technical review, ownership of and approval of Global Change Management records as required.
  • Recommend technical approaches in line with global and local standards.
  • Contribute for driving a culture of Continuous Improvement by deploying Our Company Six Sigma tools and MPS within the IPT on projects such as: problem solving, reducing cycle time, lean principles within the new processes.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
  • Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant

Qualifications:

  • Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles
  • Project management qualification such as, Project Management Professional is desirable
  • Evidence of Continuous Professional Development​


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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