Johnson & Johnson Careers
DSP Process Engineer
Requisition ID: 1905769703W
“Caring for the world … one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
Janssen Vaccines in Bern (Switzerland) belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 30,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 300 people of over 20 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products. We are committed to bring meaningful innovation to global health by combating major threats to the health of people worldwide. We are currently looking for
- SME and SPOC for allocated key equipment(s) and related process technology
- 2nd line troubleshooter and owner for 1st line medium to high impact invest.
- Owner of allocated ETS record (incl. CC’s)
- Owner of CoC for allocated key equipment and related process steps after hand over from PD to Ops
- Support by performance of tech Transfer process and creating associated documentation for DS Operations
- Authoring of draft 1st Master Batch record in close collaboration with PD and Ops
- Training of Operators on written Documents (MBR or process equipment related documents)
- Supports New technology evaluation with respect to GxP Operations applicability in collaboration with PD, Capex Engineer, PAMS members under the lead of new technology and innovation lead
- Supports Compliance team with SOP, WIs, Job aids harmonization initiatives across site
- Takes system ownership /oversight for bioreactors and UF systems
- Create system impact assessment 1 and supports IA 2 and 3
- Lead for URS creation
- Support order of equipment
- Responsible for update / maintain master data in SAP
- Creating operation documentation
- Support decommissioning
- Member of SIA team
- Support qualification (incl. FAT/SAT) and validation
- Responsible for proper performance of yearly maintenance / calibrations incl. closure of WorkOrders
- Support CSV and periodic review
- Perform Data Integrity Assessment
- Perform Data Integrity Review
- Perform Audit trail
- Identify cGMP and compliance improvements and ensure implementation
- He/she is responsible for holding and providing expertise on cGMP as it applies to manufacturing. This includes but is not limited to: Best practices on design and execution of manufacturing documentation
- He/she is responsible for input on validation assessments, review and sign off on commissioning and validation protocols and reports. Furthermore he/she is responsible for input, review and sign off on design documentation.
- He/she is a change initiator accountable for initiating and follow up on changes in line with cGMP, EHS, Production schedule and user requirements.
- He/she is responsible for aspects of cGMP and external party inspections within manufacturing. This includes but is not limited to:
- Always inspection ready for (un)announced inspections.
- When required interaction with inspectors as representative for manufacturing.
- Facilitate timely and correct response to questions and observations.
- Ensure timely execution of corrective and preventative actions for deficiencies.
- Ownership for data gathering, data evaluation and trending & writing of campaign reports and technology transfer reports
- MSc degree (or BSc with increased level of experience) in life sciences with several years of experience in GMP compliant biotechnological manufacturing or development
- Advanced knowledge of USP/DSP technology,
- Fluency in English, German beneficial
- problem solving skills and strong communication skills
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms. Have we piqued your interest? Please send us your online application (CV, Working References etc.)
Janssen Vaccines AG (8851)
R&D Engineering (R&D)