Process Engineer

PROCESS ENGINEER

ROLE: PROCESS ENGINEER

LOCATION: UFA, RUSSIA

RATE: COMPETITIVE

START: ASAP - NOTICE

TYPE: CONTRACT - 9MONTHS

My client is looking for a Process Engineer.

Please see below, essential Knowledge and skills required.

Highlighting specifics for this role:

- Must be fluent in Russian and English.
- Must be willing to relocate for the duration of the job (9months +)
- Apartment provided (only for contractor), cell-phone and 1 flight back home every 8 weeks will be provided by customer (7 weeks there, 1  week home)
- Slight extension of a couple of months at end of project is optional
- Because of the international nature of the assignment, a strong, independent personality is required

SCOPE OF CONSULTANCY SERVICES

- Consultancy Purpose
- Consultancy Areas and Tasks:
- Our client has entered into an agreement with its Russian partner in building, qualifying and validating a new cytotoxic parenteral production department in the site in Ufa, Russia, using the newest technologies, amongst others an automated filling line with automated lyo loading and isolator technology.
- My client invests in this 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 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 of my client on site, and will start with the on-going qualification and will then continue to the process validation of the new product in the new site.
- The consultancy function will team up 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 tasks involved in these activities as described below.
- PROCESS TITLE: Process Engineer for the project Stravinsky.
- REPORTING LINE: in the project, the process engineering consultancy function at in Ufa will be working closely together with and report to the Director Process Engineering.

TASKS TO BE PERFORMED:

- The objective of the function is to provide continuous professional hands-on consultancy, expertise and support to Ufa during the qualification, validation and start-up phases of a new sterile department for Velcade (plans, protocols, execution and reports) assuring that approved protocols are followed during the entire project.
- 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. The engineer must assure that misinterpretations caused by the difference in language, or its contractors do not occur.
- In alignment with QA, the function is responsible that cGMP's are followed during these activities, following approved validation plans and protocols.
- 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:

VALIDATION MASTERPLAN

The function should support in the execution of the validation master plan

QUALIFICATION (IQ/OQ): (also in cooperation with Quality Assurance Manager for the project)

- The function should focus on all new equipment with a link to Velcade. This includes manufacturing equipment such as filling, loading, lyophilisation, autoclave, isolators but also a sterility test isolator, sampling equipment, etc.
- 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)

- Supporting PQ which includes sterilization validation, media fills and cleaning validation
- Supporting Millennium during process validation (presence during process validation)
- Support in reviewing regulatory files
- Presence during the first production batches (which would be the process validation batches)
- Depending on the progress of the project is supporting the qualification and validation of clean-rooms and clean utilities and assuring that approved protocols are followed a part of the assignment.
- The function needs to partner and support the QA people representing Janssen to enhance the quality systems at PHS such as Control of Change, deviation handling, calibration, etc.
- Assist in LOCAL FOLLOW UP OF PROJECT MANAGEMENT, escalating delays to his/her 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/her capabilities and expertise.