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Applied Process Engineer - Pharma - Russia

Eingestellt von Aston Carter

Gesuchte Skills: Support, Engineering, Engineer

Projektbeschreibung

For one of our direct, international accounts, one of the leading companies within the consumer goods, pharmaceutical and medical devices industry, we are looking for a Russian speaking Applied Process Engineer to be based in Ufa, Bashkortostan, Russia.

Start date: preferably ASAP but flexible
Duration: 15 months

Scope of consultancy Services:

a. Consultancy Purpose:

* The consultancy function relates to a new cytotoxic parenteral production department in the Ufa site, 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 on site, 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
* Our client 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
* 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.
* 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): (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 and we will get in touch with you.

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. 

Projektdetails

  • Einsatzort:

    Keine Angabe

  • Projektbeginn:

    asap

  • Projektdauer:

    15 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Aston Carter