Principal Validation Specialist

Brightwater

Cork

This position will provide expert technical support for Qualification, Validation and Technical activities. You will be required to collaborate with Capital Projects on the qualification of new facilities, utilities and equipment; plus manage external venders for the provision of qualification services. This is a full time, permanent role with an attractive package on offer. Primary responsibilities: Lead and participate in problem solving teams across all areas (e.g.CAPA/DN/MDNs etc. Lead and close process related deviations and reports. Protocol/report authoring/execution/oversight/approval as appropriate. Ensure highest Quality, Compliance and Safety standards. Ensure supply of high quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives. Recommend technical approaches in line with global and local standards. Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances. Author/approve Change controls and MIDAS documents as appropriate. Qualifications and Experience: Hon. 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. > 5 years’ experience in a similiar role in a manufacturing environment. Ideally in a senior role. Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical operation (e.g. manufacturing, technology, validation, engineering, quality, analytical. Skill Set. Demonstrated process, qualification and technology SME background within the pharmaceutical or Biopharmaceutical industry. Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc. Demonstrated capability to deliver results RFT, in a FDA / HPRA Regulated production environment. Demonstrated leadership, including change management skills with a continuous improvement focus. Demonstrated ability in holding project team members responsible for results and being decisive about non-performers. Demonstrated ability to realize improvement initiatives. Demonstrated high level of problem solving and facilitation skills. Stakeholder management of multi decision makers, colleagues, peers and cross functional teams. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2346 days ago