Senior Process Engineer to work in Ufa, Russia

We are currently searching for a Senior Process Engineer to work in Ufa, Russia for 12 months with possible extensions. This is a fantastic contract opportunity for a large multi-national client.

Process Engineer for the project for local production of an oncological, lyophilized cytotoxic product.

Tasks:

* The objective of the function is to provide continuous professional hands-on consultancy and expertise during the qualification, validation and start-up phases of a new sterile department (plans, protocols, execution and reports).
* Because of the international nature of the assignment, a strong, independent personality is required, dynamic and with a lot of drive; he/she must be fluent in the Russian language and English language, and be able to integrate into a completely different culture.
* In alignment with QA, the function is responsible that cGMP's are followed during these activities.
* This should be managed in such a way that agreed timelines are followed. All the activities should lead to successful process validation; project management skills are required.

Below processes and output should be supported by the consultant function:

* Qualification (SAT-IQ/OQ): (also in cooperation with Quality Assurance Manager for the project)
o Function would begin at the Site Acceptance Tests of the filling/loading/lyophilisation equipment
o The function should focus on all new equipment. This includes manufacturing equipment such as filling, loading, lyophilisation, autoclave, isolators but also a sterility test isolator, sampling equipment, etc.
o Qualification of the compounding area is included (including isolator, CIP/SIP)
* Validation (PQ, media fills, cleaning and process validation):
o Supporting PQ which includes sterilization validation, media fills and cleaning validation
o Supporting Millennium during process validation (presence during process validation)
o Support in reviewing regulatory files
o Presence during the first production batches
* Assist in local follow up of project management, escalating delays to his supervisor and the project team
* In addition to the above assignments, the consultant will also receive requests for support of mainly a technical nature within his capabilities and expertise.

If you are interested in this position, please respond within 24 hours with your CV in Word format so MBA can contact you.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.