Biotechnology Process Engineer USP DSP

Agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Life Science Energy Infrastructure
Transportation Chemicals sectors.

As a consultant you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills. You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing whats behind closed doors of the biggest projects of our clients portfolio.

Tasks

During the tech transfer of a new biologic product to a pharmaceutical site the Process engineer will mainly be responsible for the support of local tech transfer activities (manufacturing and multiproduct facility readiness) in line with global tech transfer strategy :

Support the technical integrator in creating and maintaining a list of deliverables (for example Mass Balance BoM SingleUse Diagrams Room layout Batch Records sampling plan)

Support the technical integrator in maintaining a project timeline and deliverable tracking

Author review Tech Transfer Documents Work Instructions SOP Technical documents (URSs material specifications)

Support in coordinating local tech transfer activities for example by tracking actions and chasing action owners

Actively interface with and influence Global Tech Transfer and translate Tech Transfer strategies into local actions deliverables etc

Support the implementation of a platform process by reviewing and revising existing procedures and implementing new materials and equipment

Support SAP implementation of new materials and intermediates (CS01)

Support investigations of nonconformances

Contribute positively to a strong culture of business integrity and ethics

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

Requirements

Technical or scientific degree (e.g. biotech engineer pharmaceutical engineer process engineer chemist etc.)

Experience in the field of biotechnology production of Bulk Drug Substance

GMP experience

Good MSOffice knowledge

Ability to work in a fast paced high regulated environment

French and English (Fluent)

EU or Swiss nationality or valid Swiss working permit

Thank you for your interest in the position please note that only selected candidates will be contacted.