Process Engineer
Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!
GXP CONSULTING Switzerland is a Swiss company with a passionate 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:
R&D, Engineering, Quality Assurance, Qualification/Validation, Regulatory Affairs, Operational Excellence, Manufacturing, Maintenance, and Project Management.
About the job:
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.
- 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
About us:
- 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!
By Mail
Voie du chariot 3
1003 Lausanne
Switzerland
PO BOX 8009
