Senior Process Engineer MSAT

We are looking for a Senior Process Engineer MSAT (Fulltime, 40 hours a week) to join our Akkodis team.

Start date: ASAP

Contract: 6 month contract

Deadline to apply: 10-09-2024 before 13:00h

Scope of the job

You will be working on site at our client based in Leiden. The Senior Process Engineer is an experienced subject matter expert on automated CAR-T manufacturing processes and technology transfers in a decentralized manufacturing model. The Senior Process Engineer defines plans and procedures to transfer the process globally and progress the development of the CAR-T manufacturing processes/products from early clinical stage through pivotal/commercial readiness.

Your role

• Act as experienced subject matter expert on the automated CAR-T manufacturing process and technology transfers and clinical manufacturing in a decentralized manufacturing model.
• Define plans to ensure progress in the Life Cycle Process Validation activities through the stages of process design, process qualification and continued process verification, as well as process and product comparability.
• Lead the implementation of product/process related change controls in the global network
• Lead product/process investigations and define corrective/preventive actions
• Author process descriptions and generate relevant SOPs, Work Instructions and trainings to guide the decentralized manufacturing process in the global network of manufacturing sites
• Contribute to the development of electronic batch records, procedures and trainings for the manufacturing process
• Support initiatives for real time process/product monitoring, manufacturing equipment lifecycle & reliability.
• Contribute to the content of regulatory filings and health authority questions related to the technical process/CMC module.

Company details

We are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related.

We have +/- 60 Consultants working at the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen and many more! 

Candidate’s Profile

Job requirements

• PhD degree in life sciences, biotechnology, engineering or related discipline with at least 7 years work experience or MSc with an equivalent level of experience
• Demonstrated experience with cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfer, process validation and/or process development
• Excellent verbal and written communication skills with the ability to collaborate effectively across different functions and geographies.
• Knowledge of data management tools and statistical process controls is a plus
• Result-driven and can-do mindset, without compromising quality and compliance
• Responsibility for own projects while pursuing company goals in open collaboration. Ability to be flexible with changing priorities
• Good interpersonal skills and written and spoken fluency in English

Are you interested in this challenge or do you want to come in touch?

Apply via the button this page and/or send your CV to lifesciences@akkodisgroup.com.