Process Engineer

3 weeks ago

Municipal District of Carlow, Ireland Orion Group Full time

Orion Group Life Sciences are currently recruiting a Process Engineer (Hybrid) on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract.

As Engineering Specialist, you will lead/execute production floor-based activities, participate on a team of engineers, plan and execute validation activities as required, as well as design and develop engineering studies to support our commercial products.

The team currently consists of engineering professionals working across 4 functions on projects in collaboration with diverse teams across Engineering, Production, and Analytical Labs. Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.

Our Engineers support internal and external manufacturing operations to remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

Bring energy, knowledge, and innovation to carry out the following:

  1. Lead/execute production floor-based activities
  2. Participate on a team of engineers
  3. Plan and execute validation activities as required
  4. Design & develop engineering studies
  5. Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support
  6. Provide technical input into quality notification by authoring/reviewing/approving investigations
  7. Execution of equipment/qualification validation programs; including re-qualification and re-validation
  8. Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
  9. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
  10. Statistical data analysis to support development and commercialisation batches
  11. Support continuous improvement through Lean Six Sigma methodologies
  12. Leading and active participation in projects, system failure investigations, and investigation reports
  13. Execution/development of change controls
  14. Contribution to Kaizen events as appropriate
  15. Perform root cause analysis of system failures and substandard performance using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc.
  16. Implement subsequent corrective action through the change management system
  17. Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums
  18. Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups
  19. Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance
  20. Work collaboratively to drive a safe and compliant culture in Carlow

What skills you will need:

  1. Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
  2. Prior related work experience; ideally in manufacturing, preferably GMP Setting
  3. Typically have 3 years related work experience in Aseptic manufacturing / process engineering
  4. Knowledge of regulatory/core requirements to Irish, European and International Codes, Standards and Practices
  5. Report, standards, policy writing skills required
  6. Equipment and process validation
  7. Sterile filling processes and equipment
  8. Proficiency in Microsoft Office and job-related computer applications required
  9. Lean Six Sigma Methodology experience desired
  10. Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.

Qualifications & Education

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
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