Sr. Process Engineer
Beschrijving
- Randstad
- 4000.00 – 6000.00
- 40 hours
- Master degree
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry.
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry. They participate in interesting projects in the pharmaceutical industry. They do this by providing support to clients on challenging and varied projects. Usually with the opportunity for personal development in addition to your contribution.
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 and GMP manufacturing.
- Knowledge of Quality risk management and Quality by Design principles such as Criticality Assessment and Control Strategies
- Demonstrated experience with design and execution of process characterization studies.
- Knowledge of data management tools and biostatistics
- Excellent verbal and written communication skills with the ability to collaborate effectively across different functions and geographies.
- 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
What do you get?
- Pension entitlement as from day one
- Collective WGA / WIA insurance
- NBBU / ABU collective labor agreement
- 25 holidays days
- 8,33% holiday allowance
- 100% payment in case of illness after one waiting day
- Travel allowance
Duties
- Act as experienced subject matter expert on the automated CAR-T manufacturing process and technology transfers and clinical manufacturing in a decentralized manufacturing model.
- Develop and execute plans for Life Cycle Process Validation activities, as well as process and product comparability.
- Lead process characterization studies: design protocols, analyze data, and prepare technical reports to support process understanding and control strategies.
- Collaborate with Process Development and CMC teams to translate lab-scale processes into robust, GMP-ready manufacturing processes.Prepare and review CMC documentation, including process descriptions, comparability reports, validation protocols, and technical sections for regulatory filings.
- Provide technical input on risk assessments, control strategies, and continuous improvement initiatives aligned with global regulatory expectations.
- 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.
Interested
Send your resume to sander@tailorminds.com referring to job id (1898)
More information?
Please contact Sander Pupella working at our office in Zoetermeer, phone number +31 6-13140754
Plaats
TailorMinds - Netherlands
