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Quality Technical Specialist

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €42,000 - €55,000

Job Title: Quality Tech - Complaints

">Job Description

This is an 11-month contract position offering a competitive hourly rate. We have an amazing opportunity for a Technical Specialist in Operations – Vaccines IPT.

The Technical Specialist will provide process technical support to the Vaccines IPT team and other site departments requiring Vaccine Process knowledge. The role reports to the Vaccines IPT Associate Director.

Duties and Responsibilities:

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  • Support department and site level activities requiring process and operational knowledge.
  • Provide process operations including troubleshooting technical and process related issues and leading investigations using MPS principles (e.g. DMAIC/A3/OPPS).
  • Manage EHS and Quality investigations, coaching, completing and overseeing batch record reviews.
  • Lead cross-functional Technical Projects to further develop the Vaccine Process.
  • Support and manage Process Robustness changes and product introduction.
  • Lead cross-functional Project problem-solving teams for troubleshooting and investigations within Vaccines IPT and across the site as required.
  • Vaxneuvance POC for site compliance initiatives.
  • Provide high-level process knowledge to supporting functions and projects.
  • Support and lead material management and troubleshooting with a cost focus.
  • Apply Lean Six Sigma and Lean methodologies.
  • Represent the department on cross-functional project teams.
  • Adhere to highest standards for Compliance (Safety, Quality, and Cost).
Required Skills and Qualifications

In order to excel in this role, you will more than likely have:

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  • A degree or Master's in a Science or Engineering discipline (preferably Biotechnology).
  • >4 years' experience in biopharmaceutical/vaccines environment.
  • Knowledge in material management and associated systems.
  • Direct experience with Single Use Technology (operational use, problem solving, vendor engagement).
  • Direct experience in manufacturing with a problem-solving mindset.
  • Strong technical and process knowledge with background and experience in drug substance processing unit operations (UF/DF, Lyophilisation, Bottle filling, PAT, Single use technology deployment).
  • Strong collaboration and project management skills; able to establish good working relationships with employees at all levels, resolve conflict and provide feedback, and devise and implement creative solutions to problems.
  • Knowledge of FDA / HPRA Regulations and applicable standards for Quality and Regulatory requirements within the biopharmaceutical/vaccine area.
  • Demonstrated successes in a cross-functional team environment, such as project teams.
  • Demonstrated ability to solve complex technical problems; taking a new perspective using existing solutions.
  • Stakeholder management of multi-decision makers, colleagues, peers, and cross-functional teams.
  • Works independently, receiving minimal guidance.
  • Demonstrated ability to forecast, plan, and monitor cost with regard to material consumption.

Please click the link below to apply or send an up-to-date CV.