Assay Process Validation Engineer

작업 내용

ASSAY PROCESS VALIDATION ENGINEER

The Assay Process Validation Engineer is responsible for the cleaning and process validation of assay-specific processes as well as for the design transfer of the new assays to Manufacturing.

Accountabilities

• Validation of the process parameter settings for the assay-specific processes leading to a stable and reliable manufacturing process;
• Assess and validate for the assay-specific processes that the applied cleaning procedures are adequate, and develop new cleaning procedures if needed;
• Perform an efficient design transfer to Supply Chain, Operations, and external partners in a standardized fashion;
• Safeguard the validated state of the assay-specific production processes;
• Collaborate, support, and communicate efficiently with relevant team members, such as Assay Development, Industrialisation, Supply Chain, Operations, QC and QA to ensure processes are consistent throughout the company;
• Present own work at in-house forums and at outside professional meetings;
• Take the lead in preparing assay-specific process related documentation (process FMEA, validation Protocols and Reports, Work Instructions, batch records, etc.);
• Plan, carry out, and supervise process and cleaning validation activities;
• Continuous improvements and optimization of assay-specific validation processes.

Profile requirements

• Bachelor or Master degree in Science / engineering or equivalent through experience;
• Experience with validation activities in a GMP environment is a very strong asset;
• Preferably 3 years of professional experience in chemistry, biochemistry or molecular biology in a medical, pharmaceutical or diagnostic industrial environment
• Experience in IVD process validation is a strong added value;
• Experience in design transfer of biotechnology processes is an asset.
• Experience in methodology for statistical process control tools and risk analysis (FMEA);
• Technical leader who can function independently;
• Basic knowledge of sample preparation, NA extraction and real-time PCR;
• Excellent technical writing (protocols, reports, standard operating procedures, transfer documentation, test methods) and good documentation practices;
• Ability to interpret data and to perform troubleshooting activities;
• Good knowledge of statistical techniques, such as data trend analysis, is highly desirable;
• Applied knowledge of cleaning validation processes;
• Planning & organization – Planning & organization: plans and organizes own work(load) in an effective way by setting priorities and meeting deadlines;
• Adaptability to change – Adapting to change: accepts and implements change and adapts, even in difficult situations;
• Resilience – Continues to perform effectively under time pressure and in the face of disappointment, adversity and opposition;
• Communicating & influencing – Communicates with clarity: speaks and writes clearly and to the point; active listener;
• Analytical thinking - Gathers information from varied sources, analyzes data in a critical way using common sense and logical thinking;
• Legislation and regulation: basic understanding of ISO13485, ISO14971, 21CFR820 and MDSAP;
• PC skills:
• Microsoft Office (Word, Excel, Powerpoint and Outlook)
• Spotfire
• Languages: advanced knowledge, orally and written in Dutch and English.

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.