Process Engineer - Russian Speaking

We are looking for an Applied Process Engineer to be on our client's site in Ufa, Bashkortostan, Russia. The engineer should speak English and Russian!

Accomodation and payment for flights is foreseen by our client.

Scope of consultancy Services

a. Consultancy Purpose
* The consultancy function relates to a new cytotoxic parenteral production department in the site of in Ufa, Bashkortostan, Russia, using the newest technologies, amongst others an automated filling line with automated lyo loading and isolator technology
. The consultancy function will have to represent Global Technical Services, and will start with the Site Acceptance Testing, and then continues to the process validation of the new product in the new site.
. The consultancy function will partner with 2 QA persons on site in Ufa.
. The partner invests in the new production site and is responsible for the project to install, qualify and validate the site, utilities, equipment and production process of the involved product. The consultancy function shall support the process engineering tasks involved in these activities as described below.

b. Consultancy Areas and Tasks :

* Process title : Process Engineer: local production of an oncological, lyophilized cytotoxic product in Ufa, Bashkortostan, Russia

* Reporting line : in the project, the process engineering consultancy function will be working closely together with and report to the technical director of the project of the Parenteral Technical Platform

Tasks to be performed in the Russia Project :

* 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.

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): (also in cooperation with Quality Assurance Manager for the project)
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

* Building and Utilities :
o Support only on specific request

* 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.

Please apply with your English Word CV.

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