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Technology Transfer Engineer

Reference:JSC000039480
Location: Cork
Qualification:Degree
Experience:3-4 Years
Job Type:Fixed Term Contract
Salary:Not Disclosed
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May be suitable for: EHS Engineer

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties


Reporting to the QE Leader, the Technology Transfer Engineer shall lead from a Quality perspective.
The job holder will lead the QA element of process / technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and R&D personnel ensuring timely communication to all stake holders to effect successful project completion.

MAIN DUTIES & RESPONSIBILITIES:

  • Represent Quality as part of a cross functional team to ensure delivery of projects (NPI’s and Technology) into production with the highest level of quality, compliance, and adherence to timelines
  • Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
  • Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production
  • Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
  • Liase with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development
  • Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error.
  • Lead QA input to Design for Manufacture activities on site.
  • Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR’s and ISO 13485/9001 requirements etc. during all day to day
  • Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
  • Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap and reprocessing.
  • Assist in the development, review and approve product, gauge, tooling and fixturing drawings.
  • Maintain a good level of house-keeping in designated areas, and observe all Health and Safety at work requirements.
  • TO ADHERE TO THE COMPANY’S PROCEDURES AS DETAILED IN THE CSOP MANUAL


KEY COMPETENCIES REQUIRED

  • Culturally aware
  • Flexible
  • Team player
  • Good influencing skills
  • Project Management skills
  • Good generalist (experienced quality person)
  • Methodical
  • Defuser, not inflame
  • Good communicator
  • Politically sensitive
  • Travel Flexibility

Education & Experience

-A degree level or similar qualification in mechanical or industrial engineering.
-Minimum 3years experience in a quality role within a regulated industry.
-Proven ability to successfully introduce new product development in the Medical Device Industry.
-Proven knowledge and ability regarding product verification and process validations.
-Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
-Proven experience and training in Mechanical Engineering processes.





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