MES Design Engineer (a) 100% — Bachem AG
NewCHF 49'500 - 75'000
Bachem AG · Stein AG (AG)
- Location
- Stein AG
- Contract
- full-time
- Posted
- Yesterday
SalaryCHF 49'500 - 75'000
Role overview
For the construction and commissioning of our new pharmaceutical production facility, we are looking for a dedicated MES Implementation Engineer with experience in PAS-X.
Our goal is a completely paperless production in which the MES is seamlessly integrated with automation systems such as Siemens PCS 7 / PCS neo.
They significantly contribute to the fact that we can realize a highly efficient, GMP-compliant and digitalized manufacturing process including Review by Exception. Your
- For the construction and commissioning of our new pharmaceutical production facility, we are looking for a dedicated MES Implementation Engineer with experience in PAS-X.
- Our goal is a completely paperless production in which the MES is seamlessly integrated with automation systems such as Siemens PCS 7 / PCS neo.
- Implementation, configuration and validation of the MES system PAS-X for the new production line Development and design of electronic master batch records (eMBR) taking into account GMP standards and process requirements Integration of the MES with the process control system (PCS 7 / PCS neo) to automate data flows and reduce manual inputs Implementation of an efficient review-by-exception concept for quality optimization and reduction of review effort Close cooperation with production, automation, quality and IT as well as global units for the definition and implementation of system requirements Ensuring data integrity, GMP compliance and traceability of manufacturing processes Participation in qualification and validation activities (URS, FS, IQ, OQ) Training and support of end users in dealing with the MES Ongoing further development of the system and support for change control processes Your profile: Completed studies in chemistry, life science, engineering, pharmaceutical technology, computer science or a comparable qualification Several years of experience with PAS-X in a GMP-regulated environment (power user level) In-depth knowledge in modeling eMBRs and MES workflows Experience in integrating MES with PLS systems, especially Siemens PCS 7 (and ideally PCS neo) Good knowledge of regulatory
- Requirements (GMP, GAMP 5, Data Integrity, Annex 11 / CFR Part 11) Analytical thinking, structured working methods and affinity for digital solutions Communication strength and teamwork in an interdisciplinary environment Optional: Experience in administration of Windows and Windows Server systems, databases, and network skills Knowledge of IT system / software qualification (GMP, GAMP, CSV) Basic knowledge of automation (OPC UA) is an advantage Strong team and communication skills as well as structured, documentation-oriented working methods Good knowledge of German and English in word and writing Our offer: <span style="font-size:10.0pt;font-family:Arial",
Main responsibilities
- Implementation, configuration and validation of the MES system PAS-X for the new production line Development and design of electronic master batch records (eMBR) taking into account GMP standards and process requirements Integration of the MES with the process control system (PCS 7 / PCS neo) to automate data flows and reduce manual inputs Implementation of an efficient review-by-exception concept for quality optimization and reduction of review effort Close cooperation with production, automation, quality and IT as well as global units for the definition and implementation of system requirements Ensuring data integrity, GMP compliance and traceability of manufacturing processes Participation in qualification and validation activities (URS, FS, IQ, OQ) Training and support of end users in dealing with the MES Ongoing further development of the system and support for change control processes Your profile: Completed studies in chemistry, life science, engineering, pharmaceutical technology, computer science or a comparable qualification Several years of experience with PAS-X in a GMP-regulated environment (power user level) In-depth knowledge in modeling eMBRs and MES workflows Experience in integrating MES with PLS systems, especially Siemens PCS 7 (and ideally PCS neo) Good knowledge of regulatory
- Requirements (GMP, GAMP 5, Data Integrity, Annex 11 / CFR Part 11) Analytical thinking, structured working methods and affinity for digital solutions Communication strength and teamwork in an interdisciplinary environment Optional: Experience in administration of Windows and Windows Server systems, databases, and network skills Knowledge of IT system / software qualification (GMP, GAMP, CSV) Basic knowledge of automation (OPC UA) is an advantage Strong team and communication skills as well as structured, documentation-oriented working methods Good knowledge of German and English in word and writing Our offer:
Additional details
- They significantly contribute to the fact that we can realize a highly efficient, GMP-compliant and digitalized manufacturing process including Review by Exception.
- Tasks: Implementation, configuration and validation of the MES system PAS-X for the new production line Development and design of electronic master batch records (eMBR) taking into account GMP standards and process requirements Integration of the MES with the process control system (PCS 7 / PCS neo) to automate data flows and reduce manual inputs Implementation of an efficient review-by-exception concept for quality optimization and reduction of review effort Close cooperation with production, automation, quality and IT as well as global units for the definition and implementation of system requirements Ensuring data integrity, GMP compliance and traceability of manufacturing processes Participation in qualification and validation activities (URS, FS, IQ, OQ) Training and support of end users in dealing with the MES Ongoing further development of the system and support for change control processes Your profile: Completed studies in chemistry, life science, engineering, pharmaceutical technology, computer science or a comparable qualification Several years of experience with PAS-X in a GMP-regulated environment (power user level) In-depth knowledge in modeling eMBRs and MES workflows Experience in integrating MES with PLS systems, especially Siemens PCS 7 (and ideally PCS neo) Good knowledge of regulatory
