Process Engineers USP and DSP
- Catégorie: Automation, Mecatronique, Systèmes embarqués / Electronique
- Type de contrat: CDI
- Localisation: Lausanne, Suisse
- Niveau de formation: Master/ingénieur
- Expérience/Années: > 3 y
Mission
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 / re qualification and validation of electronic systems
PROFIL
You hold a Master’s degree in Computer Systems, Chemical, Mechanical, Electronic Engineering or Information Technology
You have at least 3-years experience in a manufacturing environment with information and / or automation technology systems
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 French/English. Good knowledge of German is aplus