Caring for the world, one person at a time ‘… inspires and unites the people of Johnson & Johnson, we embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Janssen Pharmaceutica is part of Johnson & Johnson and brings innovative medicines towards patients throughout the world.
The Drug Product Development & Supplies is part of the Pharmaceutical Development organization and plays a crucial role in delivering medicines to our patients during the development phase of a new product. Within this organisation the Pilot Plant is responsible for the upscaling and fine tuning of formulation and processes which result in the successful clinical manufacturing of new Drug Product (DP).
For our DP pilot plant in Beerse we are looking for a Principal Engineer.
This role will work with the Associate Director Engineering of the Drug Product Pilot Plant – Drug Product Development & Supplies and will be based in Beerse.
Responsibilities Include, But Are Not Limited To:
- As principal engineer for all Solids manufacturing equipment, with a particular in-depth focus on continuous manufacturing technology, you will:
- Have a full understanding of the technical aspects of the equipment and sufficient awareness of the related processes and operations
- Analyse process and project requirements and accordingly provide technical and functional recommendations
- Keep your knowledge up to date by training, peer learning, networking …
- Build relationships with suppliers and partners
- Share knowledge in the organisation: you act as the “go to” person for questions and problems
- Be the core team member for the Mirror project (Cont. Mfg.) in Latina
- Project Management of multidisciplinary teams and accountable for the design, installation, commissioning and qualification of equipment including:
- Definition and alignment to the project scope, planning and budget
- Project team organisation
- Creation of business case and aCAR for new projects/investments
- Writing of technical specs and leading the tendering process
- Build FAT, SAT and commissioning test scripts and execute
- Supervise construction in the field
- Creation of life cycle and qualification documents (URS, Risk assessment, IOPQ, …), full qualification and deviation handling.
- Organisation and participation in assessments such as CC, SWIFT, HAZOP, FMEA, …
- Spokesperson for equipment qualification by inspections.
- Approval of qualification documents (URS, PQP, IOPQ, …), system approvals (SAP, Trackwise, …) and procedures (TruVault)
- Lead and support specific strategic investments through feasibility studies, capacity analysis, technology screening and strategic project management
- Evaluate existing engineering processes and recommend improvements.
- Master’s degree in Engineering
- Proven experience in Pharmaceuticals engineering with a minimum of 7 years.
- Profound knowledge of Solids equipment: feeders, blenders, spray dryers, granulators, tablet presses
- In depth knowledge of continuous manufacturing is an asset.
- Consistent track record in project delivery (budget, timelines & project objectives) – experience with FPX methodology or equivalent project management tools
- Full understanding of GMP in equipment design, machine directive, ATEX regulations, PED, piping standards, risk analysis methods (HAZOP, FMEA)
- Good basic knowledge of automation systems like PLC and DCS including Data Integrity aspects, user access, security settings and CFR21 part 11
- Strong organisation and prioritisation skills
- Strong communication skills
- Good in developing relationships with the ability to build partnerships and collaborate both internally and externally
- Dutch – native or bilingual
- English – full professional proficiency
- Advanced in MS project and Microsoft Office (Excel, Word, …)