AdresData & systems engineer - 2406176919W
Description
J&J Innovative Medicine is recruiting for Data & Systems engineer, located in Leiden.
Job Description Data & Systems engineer
The Research & Development group of J&J Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases, and vaccines, cardiovascular and metabolism, and pulmonary hypertension.
The Drug Substance Development (DSD) department in Leiden focuses on advanced therapies, a novel class of medical products that uses cell and gene therapies to treat diseases which have the potential to cure diseases when no treatment is available. It's a very exciting field, as no established manufacturing platforms exists for these products, which means that new processes need to be developed to ensure high-quality and efficient production of GMP material.
The DSD process development and GMP manufacturing teams work as one team to enable fast delivery of the products for clinical trials, by together developing the process, tech transferring it to the GMP pilot plant and then producing the clinical trial material.
We are recruiting a data and systems engineer to join our GMP manufacturing teams. We are seeking a highly motivated and independent individual who will be very involved in all aspects of managing the process data generated in the plant, as well as the process and equipment data systems in the plant.
Key Responsibilities:
Own the introduction of new equipment to the plant’s data systems and work with broader teams as the plant representative on the introduction of new data systems
Ensure data integrity of both new production equipment, by giving input in the purchase of new equipment, and existing equipment, through audit trail reviews and inspections.
Work with the production teams to build electronic batch records for new processes.
Collaborate with a cross-departmental team to build a multi-year systems, automation and data strategy for the GMP pilot plant
Ensure fast data availability of production data to the process development teams
Build dashboards to showcase production data and help the production teams operate more optimally
Qualifications
Qualifications
Education:
BSc or equivalent with 2-5 years or MSc or equivalent with 0-2 years of Pharma/biotech industry experience.
Experience and Skills:
Experience working with data historians like OSI Pi
Good understanding of GMP data requirements (e.g. part 11 compliance)
Ability to code effectively in Python
Previous experience with SCADA systems like Delta-V is beneficial
Familiarity with data lakes or data warehouses would be helpful in the role
Experience creating batch records is a plus
Strong connect and teamwork skills.
Project management skills
Strong communication skills in English
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization Janssen Vaccines & Prevention BV (8852)
Job Function Data Engineering
Req ID: 2406176919W
