Equipment Process Engineer (Aseptic Sterile Fill Finish)

Asset Engineering Recruitment Ltd (Carlow, Ireland) 18 days ago
Equipment Process Engineer (Aseptic Sterile Fill Finish)

Asset Recruitment is currently recruiting for Equipment Process Engineers (Aseptic Sterile Fill Finish) the successful candidates will be based onsite at a multinational Biopharmaceutical facility in Carlow, Ireland. These roles will be for initial 12 month contract duration.

Duties:

* Defining and reviewing equipment specifications and associated test documentation

* Troubleshooting equipment with particular emphasis on process cycles - cleaning, sterilizing, containment

* Maintenance of process cleaning and sterilization cycles for new product introductions

* Strong focus on disciplined Root cause analysis

* 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 start up activities and new product introduction

Required Qualifications:

* Degree in Chemical or Process Engineering or equivalent

* Postgraduate Qualification in Engineering or Science discipline advantageous

* Qualification in Project Management advantageous

Experience

* Min 5 years’ work experience in a Biologics or GMP environment as part of an Engineering, Technical Services or operations function ideally with Fill Finish Operations, Biologics Systems and Process knowledge.

* Execution of CQV of Process Equipment (e.g. Bioreactors / Process Vessels, Chromatography, Ultrafiltration, Autoclaves, Parts Washers).

* Knowledge and experience with Facility Start-Up Projects (brown field or green field).

* Equipment Vendor Package Ownership and System Design Coordination

* Technical Knowledge of process monitoring systems, automation systems (DeltaV), Operational Intelligence & Data Systems (Pi System) within a GMP manufacturing environment - beneficial and desirable but not a necessity.

* Qualification of GMP Utilities, Systems and Processes - WFI, Clean Steam, CIP, SIP.

* CQV of Lyophilisation equipment

* Troubleshooting and Providing Technical and Engineering Solutions for GMP Manufacturing Operations and Equipment in a Biologics Processing Environment.

* Full proficiency in automation and knowledge of GAMP5 and CFR21 part 11 compliance

* Cycle development and validation for sterile manufacturing

* Ability to understand engineering processes through a logical, data driven hands on approach
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Equipment Process Engineer (Aseptic Sterile Fill Finish)

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