Process Engineer II Upstream
Incyte Corporation
Yverdon,
vor 1 Tg.

During the construction and facility startup phase you will be the process engineer responsible for process and equipment design and responsible to support the commissioning and qualification of USP equipment and areas.

This may include medium preparation, inoculum, bioreactors (rockers, STR), depth filtration, and cell clarification equipment.

During manufacturing operation, the process engineer will develop in an equipment and process engineering support role, mainly owning manufacturing scale equipment and process.

During manufacturing operation, the process engineer will develop in an equipment and process engineering support role, mainly owning manufacturing scale equipment and process.

Duties and Responsibilities

During the construction phase, you will mainly :

Lead process and equipment FMEA risk assessment, GMP reviews

Author, review and maintain comprehensive systems requirements (URS)

Lead the definition of USP process equipment Functional Specifications

Actively participate in the definition and review of the Qualification Master Plan

Review Vendor Quality & Project Plans and Qualification / Test Plans

Actively participate in Regular calls, visits, status updates with process equipment manufacturers

Support FAT, SAT, IQ, Commissioning and OQ. Up to25% European travel required

Support the development and implementation of process validation plans including protocols in cooperation with the Validation / Qualification Group

Assess Change Controls and deviations including any corrective actions arising during verifications

Revise and approve test reports

Support USP equipment integration within the facility

Lead PQ activities

During the operation phase, you will mainly :

Author, review, approve, maintain life cycle ( etc.) all required Standard Operating Procedures, Work Instructions, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required

Act as a mentor to USP manufacturing team members and lead by example to ensure integration of good engineering practices

Proactively propose problem resolution to process and USP equipment

Assess events, deviations and non-conformances

Raise, investigate, assess and close Change Controls.

Prepare and deliver process and technology overview training

Actively participate in process and technology transfer

Requirements

BSc, Master or Engineering Degree in Pharma / Biotech engineering

Relevant experience in biotech industry related to cGMP drug manufacturing, process design, equipment qualification, change control, equipment modification, and process validation

Direct experience in FMEA, root cause analysis, and associated quality assessment tools

Typically minimum 5-7 years of experience

Ability to work in a fast paced high regulated environment

French and English (Fluent)

Team work oriented mindset

Contribute positively to a strong culture of business integrity and ethics

Act within compliance and legal requirements as well as within company guidelines

We Respect Your Privacy

Learn more at : http : / / www.incyte.com / privacy-policy

The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.

During the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job.

You can learn more about this process here.

You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority.

Please contact privacy incyte.com if you have any questions or concerns or would like to exercise your rights.

Disclaimer : The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.

They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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