Are you passioned about the Life Sciences? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industryleaders? YES? SO DO WE!
GXP CONSULTING Switzerland is a swiss consulting company with a passioned team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle in the following areas:
Quality Assurance, Qualification/Validation, Regulatory Affairs, Operational Excellence,Engineering, Manufacturing and Maintenance and Project Management.
Learn more about us by visiting our webpage www.gxp-cs.com
In order to continue tosuccessfully support our clients, currently we are looking forProcess Engineers:
About the role:
The process engineer ensures electronic processes in manufacturing are specified and designed in an integrated, efficient manner ensuring cost, productivity, quality and safety. He will be a subject matter expert for understanding production processes such as USP; DSP, Media Buffer preparation & hold as well as CIP/SIP and related recipe structures. In operations he is also responsible for trouble-shooting challenging equipment / automation issues to improve manufacturing performance. Furthermore, managing of Value Stream mapping including related KPI is a key area to enhance existing processes.
About the job:
- Create, configure and develop electronic manufacturing processes (Drug Substance, Fill/Finishing, Shared Services, Plant Logistics)
- Prepare specifications and related design documents
- Oversee the design of PCS, MES process steps and ensures that control and execution systems are established to ensure manufacturing requirements are met
- Ensure process design ensures quality and stability of automation systems
- Develop and perform experimental process tests / qualifications with respect to efficiency, method, quality, etc.
- Create and manage process documentation and operating instructions
- Define, measure and analyze electronic processes
- Execution of electronic processes PCS, MES
- Assure the efficient operation of PCS, MES processing and information technology systems in manufacturing areas
- Define and implement improvements of automated processing and information technology systems to ensure increased manufacturing efficiencies
- Oversee investigations of automation anomalies and problems, identify root causes and implement corrective and preventive measures to prevent recurrence
- Innovation and continuous improvement
- Ensure cGMP requirements for electronic manufacturing processes
- Ensure GAMP5 and cGMP FDA CFR 21 part 11 for electronic processes are met
- Oversee qualification / requalification and validation of electronic systems
- You hold a Master’s degree in Computer Systems, Chemical, Mechanical, Electronical Engineering or Information Technology
- You have at least 5-year experience in a manufacturing environment with information and / or automation technology system
- You possess experience with these platforms: OSI-PI, Siemens PCS7, Siemens MES, SQL
- You have experience with data analysis and data mining
- You have some knowledge of Lean Six Sigma
- You know GAMP5 and FDA CFR 21 part 11
- You are fluent in English. Fluent in German is a big plus
- Human-sized company with colleagues from diverse cultural and professional backgrounds
- Open communication
- Joint team spirit
- Continuous learning and development thanks to internal trainings and workshops
At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!
If you also share the same passion and values, we will be glad to hear from you!Send us your application via email: firstname.lastname@example.org