Plant & Process Engineer (m/f) Job

Job description

Plant & Process Engineer (m/f)-0000118HDescription"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 are anchored in the internationally applicable Credo.
Cilag AG in Schaffhausen manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products and we have an impressive pipeline of new and innovative products.
PDMS F2P2 is part of the global Janssen Research & Development organization within Johnson & Johnson and is currently recruiting for a Plant & Process Engineer
- Drug Product Clinical Supply Chain.
The PDMS Clinical Supply Chain holds the global responsibility all clinical supplies of Janssen Research & Development. Our activities include all in-house and outsourced planning, manufacturing and distribution of clinical supplies (API, Drug Product, Packaged Clinical Supplies), through a global network. We supply more than 60.000 patients in more than 300 clinical trials every year.
Plant & Process Engineer (m/f)Your main tasks will includeThe Plant & Process Engineer is responsible for Engineering, Qualification & Validation support on process equipment, utility and computerized systems in PDMS.
- System Owner process equipment in the Fill & Finish pilot plants, review qualification documents, calibration, deviation handling and COC.
- Project Management during introduction of new systems and processes, defining business case, responsible for the capex plan, control of ordering and invoicing process
- Defining URS, design documentation, commissioning & testing protocols in collaboration with production personnel, equipment suppliers and quality assurance
- Instruction and training of employees on system and process level. Support in the evaluation and qualification of new Technology-Platforms/Processes in the aseptic environment
- Cross-cutting project collaboration with other engineering functions at the local campus level and in the global engineering environmentQualificationsYour profile
- Preferably mechanical or Pharmaceutical Process engineering degree or equivalent with skills to use process engineering and technology knowledge for the development and/or production of pharmaceutical processes
- In depth knowledge of liquid and parenteral processes and sterilization technologies: conventional as well as innovative platforms like lyophilisation, nanomilling, nasal spray, …, Working knowledge of solid dosage, medical devices, packaging systems, is also preferred.
- Basics about Microbiology and Chemistry
- Specific expertise: Process Engineering & Scale-up
- Elementary technical background (mechanics, electrical, PLC, pneumatics,…)
- Rules:
- Internal: J&J / JPh-standards & guidelines, applicable Standard Operating Procedures, Engineering Technical Standards, Technical Safety Standards, Industrial Hygiene Standards, …
- External: GXP, Regulatory requirements
- MS office applications
- Elementary concepts of HVAC-systems
- Isolator, cleanroom technology and high containment systems.
- IPC and monitoring systems.
- Basic concepts of CSV (computer system validation) systems.
- Equipment qualification, validation and change management systems.
- Specific tools such as ATS (analytical trouble shooting), PE (process excellence tools), Planning tools (MS-project), …
- Good documentation practices
- Excellent knowledge of German and English (spoken and written)We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and an excellent infrastructure.
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.).A strong succession pipeline has been identified however relevant applications are welcomed. Please note that this posting will expire on 07.10.2015.Primary Location:Europe/Middle East/Africa-Switzerland-SchaffhausenOrganization: Cilag AG (8562)Job Function: R&D