What you need to know

A leading pharmaceutical company based in in Co. Dublin are looking for an experienced Maintenance Process Engineer to join their team on a fixed term contract This is an excellent opportunity to working with a leading, reputable company.

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Key duties & responsibilities:

• Support establishment of the commercial process and routine manufacturing by:
  • Supporting experimental design, execution, data analysis and interpretation.
  • Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
  • Supporting deviation management.
  • Supporting change control prioritization and implementation.
  • Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.
  • Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
  • Applying LeanSixSigma tools by:
    • Securing continuity of an appropriate LSS/CEM level of knowledge.
    • Facilitating problem solving & risk assessment (FMEA) projects/meetings.
    • Making problems visible and strive for continuous improvement.
  • Serving as a key member during internal audits and external inspections/audits
• Lead and support various manufacturing science and technology organizational initiatives as needed.
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

What are we looking for?

• Minimum 5 years relevant experience ideally in a pharmaceutical environment.
• Bachelors degree in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry
• Have excellent communication skills both written and oral.
• Self starter. Ability to work individually and as part of multi-disciplinary teams.
• Experience maintaining injection moulding machines desirable
• Working knowledge of GMP and relevant regulatory requirements.

Apply for this job now or get in touch with Breda Dooley on 09064 90485

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