Process Engineer

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The Process Engineer will be responsible for providing support for technology transfer of new/existing drug substance manufacturing processes to the North Dublin facility, and will be required to work in close collaboration with Process Development, Operations, Engineering, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification.

The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, supporting start-up studies, building process data packs and performing process monitoring, study protocol generation, execution and report writing.

Role: Process Engineer

Contract: 7 months opportunity to extend

Location: Dublin North

Principal Responsibilities:

* To provide technical process support in the area of media preparation, large scale cell culture bulk drug substance manufacturing process to support the successful startup of the facility.

* Working knowledge of typical cell culture unit operations, cause and effect, collation of data and trends. Performing process monitoring/trending.

* To author and review process supporting documentation, gap assessments, technical protocols and reports, process validation documentation, strategy documents.

* To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.

* To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.

* Partner with Operations to support protocol completion, execution and sample reconciliation.

* To generate documentation reports for plant supporting studies and technical studies on the manufacturing floor at commercial scale.

Qualifications and Education:

* B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering

* Minimum 1-2 years' experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.

* Technical and operational knowledge of multiple unit operations in upstream processing, including media preparation, mammalian cell culture, centrifugation & depth filtration.

* Understanding of technology transfer, scale-up process and cleaning verification/validation is advantageous.

This is a great opportunity to join a truly global community. Not sure yet? No CV ready? Give me a call on 01-8883477 for more information!

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales