Johnson & Johnson Careers
Requisition ID: 1905756918W
Janssen Research and Development, LLC, a member of the Johnson and Johnson Family of Companies, develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.
For the Discovery, Product Development & Supply (DPDS) Department located in Schaffhausen, Switzerland we are looking for a
Senior Engineer (m/f).
In this position, you will be responsible for generating production master batch records (recipes) for incoming products, using the site manufacturing execution system (MES), in close collaboration with the local manufacturing group and global stakeholders. You will establish Manufacturing Sciences expertise across different equipment platforms for drug product development & manufacturing with focus on Parenterals. You will represent Clinical Supply Chain (CSC) pilot plants in development and clinical/commercial supply teams ensuring timely clinical supplies for bulk drug product.
- Responsible/Subject Matter Expert for the electronic master batch records for new products using the site MES system
- Works in collaboration with manufacturing team to assure lifecycle management of electronic batch records
- Drives development with MES Systems Group to improve integration, efficiency and compliance of the electronic batch records with focus on parametric release
- Ensure on-time plant readiness to support experimental / clinical activities
- Ensure timely delivery of clinical material from internal pilot plants
- Provide pilot plant input & requirements to DPD to ensure adherence of DPD-activities in the Pilot Plant to CSC-processes
- Support scale-up and Tech-Transfer
- Subject Matter Expert for technology platforms being used within the Pilot Plant & across extended network
- Assess new technologies / applications: feasibility, business case, conceptual design, installation and implementation
- Acts as the tech transfer receiving party for pilot plant and supports the Tech-Transfer and technical project implementation of early to late stage compounds (preclinical and clinical) into the Fill/Finish plants
- Ensures that manufacturing relevant information and technical capabilities are in place for the operations team to flawlessly produce the DP according to GxP, EHS and business requirements
- (Back-up) System Owner pilot plant equipment: review qualification documents and master batch records, calibration, deviation handling and COC. Spokesperson during audits and inspections
- Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents
- Actively participates in individual or team-based scientific development activities and cooperates in internal / external scientific communities and knowledge networks
- Ensures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
- You have a degree in Engineering Sciences, Information Technology, Automation or comparable experience in pharmaceuticals or in a related field with at least 5 years of experience OR a PhD with at least 3 years of experience
- Basic understanding of MES Systems with experiences to develop recipes for electronic batch records
- Demonstrated competency and experience in biologics drug product development within the biopharmaceutical industry is preferred
- Knowledge and experience of biopharmaceutical process design is preferred
- You have an outspoken interest in data-analysis and related technology.
- Strong knowledge and experience of technology transfer operations is preferred
- Strong knowledge and experience in fill/finish operations is preferred
- Proven track record of creativity and problem solving. Ability to collaborate with cross functional teams is a must.
- Excellent oral and written language skills in German and English.
Cilag AG (8562)