Senior Product Development Engineer

4 days ago

Cork, Cork, Ireland beBeeTechnical Full time €90,000 - €120,000
Job Overview

As a Sr. Engineer, you will play a key role in supporting the development and manufacturing of biologic drug products.

Key Responsibilities:
  • Supporting filling operations and working in a matrix team environment with process development, QA, QC, analytical sciences, packaging, supply chain, and regulatory teams to achieve project objectives.
  • Developing process comparisons, risk assessments, managing technical and manufacturing risks, and identifying appropriate mitigations.
  • Authoring technical reports to support DP process and product characterization.
  • Managing change control, deviations, and CAPAs through the quality management system until closure.
  • Facilitating investigations, root cause analysis for deviation resolution, data gathering/analysis, and providing technical assessments for deviations.
  • Initiating and leading process improvement projects involving cross-functional teams.
  • Supporting the technical delivery of new product introductions and tech transfer projects by closely collaborating with cross-functional project teams, ensuring compliance with specifications, regulatory guidelines, and right-first-time delivery.
  • Assisting with PPQ campaign readiness and providing in-person, on-the-floor execution support for technical runs and PPQ campaigns as required.
  • Supporting on-site implementation of changes and DP launch activities.
  • Supporting aseptic filling operations (vials and pre-filled syringes) for technology transfers and life cycle management, overseeing new product introductions from development batches to approval and commercialization.
Requirements:
  • Strong understanding and hands-on experience in MSAT or process development or technology transfer, background in large-scale processing of biologic drug products.
  • Possess a strong understanding and hands-on experience in MSAT, process development, or technology transfer, with a background in large-scale processing of biologic drug products.
  • Have a solid understanding of regulatory requirements and guidelines.
  • Proficient in technical writing.
  • Demonstrated ability to build strong partnerships and work effectively with diverse team members in a dynamic environment.
  • Excellent organizational, interpersonal communication, and problem-solving skills.
  • Capable of identifying, communicating, and implementing continuous process improvements.
  • Ability to multi-task and manage tight timelines in a fast-paced environment.
  • Able to work on the manufacturing floor for extended periods during the execution of technical protocols.
Benefits:

This is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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