Process Engineer II Upstream
Incyte Corporation
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


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

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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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