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Equipment Process Engineer (Lyo - Aseptic Sterile Fill Finish)

Reference:AMCD-815372 Location: Sligo
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Equipment Process Engineer (Lyo - Aseptic Sterile Fill Finish)

Our Client, One of the Global pharmaceutical companies based in Sligo is currently sourcing for Equipment Process Engineer . Thesuccessful candidate willsupport in the delivery, installation, commissioning, qualification and cycle development of an IMA Lyomax 25 Freeze Drier.

The Role

·Will be site engineeringSubject Matter Expertfor IMA Lyomax Freeze Drying equipment from design phase to sustaining operations.
·Defining and reviewing equipment specification and associated test documentation
·Troubleshooting equipment with particular emphasis on process cycles (e.g cleaning, sterilizing, containment)
·Strong focus on disciplined Root cause analysis
·Maintenance of process cleaning and sterilization cycles for new product introductions
·Coordinate the training of engineering/operations personnel on all technology and process, ensuring cGMP compliance.
·Coordinating Facilities / Utilities Requirements
·Setup and maintain manufacturing area equipment in compliance with the calibration and maintenance programs
·Participate in the internal EHS and Quality audits
·Lead engineering startup activities and new product introduction

The Person

·Third level honours degree in Science/Engineering based discipline
·Minimum of 5 years’ experience in Freeze Dryers, Autoclave; Steam in Place (SIP) / Clean in Place (CIP) skids
·Will have an extensive knowledge and experience with Freeze Driers, ideally IMA based units
·Experience with commissioning, and validation of Lyophilisation equipment
·Will have a high level of proficiency in automation and knowledgeable on GAMP5 and CFR21 part 11 compliance
·Demonstrates a high level of Technical understanding with keen ability to trouble shoot technical issues
·Ability to understand engineering processes through a logical, data driven, hands on approach
·Experience in Cycle development and validation for sterile manufacturing

If you would like further Information you can contact the recruiter directly:

Jannet Diana | Tel: +353 (0) 1 507 9255