|Sector||Pharmaceuticals & Biotechnology|
We are currently looking for an engineering consultant to support a leading biotechnology company based in Nancy, France in bringing and implementing in a new Freeze dryer onsite.
The Project :
- Purchase a new freeze dryer (3rd) on the basis of the existing model to ensure the "likeness" with existing freeze dryers (to minimize the impact on the regulatory and avoid change folder): vessel size, number of shelves , overall performance ...
- Modification 1: Switch to a cold system LN2 liquid nitrogen trap and on shelves (direct expansion or via a secondary network)
- Modification 2: soft Reuse TELSTAR for driving the same
The system chosen for cooling should be transposed on the 2 existing freeze dryers freeze dryer The 3rd project must be constructed to minimize the
impact on production (mainly related to the "revamping" of clean rooms) and the availability of freeze dryers
- Representing the technical choices made by engineering; understanding the challenge and discussing with stakeholders (HSE, QA, PROD, Maintenance...)
- Participate in Budgetary and organizational assessments of the future project
- Liaise with other team members (Quality, QA, IT, Supply, Tech Services etc)
- Ensure adequate and effective reporting on the mission (progress, problem solving, planning,...) and communication with the engineering teams.
- Proficient in French and English (German is nice to have).
- An expert on Freeze dryers/ Lyophilization
- Must have general understanding of cooling systems by gas compression/expansion (HFC or Nitrogen)
- Ability to grasp process subsets/ method in connection with the project activities involved (read/write functional analysis, general understanding of subset process equipment such as valves, pumps, security organs...
- Quality understanding - FAT/SAT/ IQ/OQ/PQ, Computer validation, document management, regulatory dossier and GMP.
- Engineering experience within the Pharmaceutical, Biotechnology, Biologics or Chemical industry