Engineer - MES Pharmasuite
On behalf of our client based in Switzerland, Next Ventures are urgently seeking an MES Engineer for the following project:
For the MES Business Management Team in a new facility we are looking for a contractor to support our Manufacturing Execution Systems during the project/startup phase in the Small Molecule Drug Product (SMDP) manufacturing area.
One of your responsibilities will be the support of the Manufacturing Execution System. You will model and test master recipes, specify and test new system functions and prepare the 1st Level Support for the end users. You will be in close collaboration with Business, Quality Assurance and IT. To be prepared for the job an intensive training will be carried out at the beginning of the employment.
You will be also the deputy of the Single Point of Contact (SPOC) for the global SMDP sites in the MES CORE project. In this role you will work in a team with other SPOC’s and Global Informatics in order to enhance the features of the new MES and raise the quality of all project relevant documents.
• Start date: 03.07.2017
• Latest start date: 01.09.2017
• End date: 01.04.2019
• Extension: An extension is currently not planned.
• Work load: 100%
• Work location: Kaiseraugst
• Remote: Not possible
• Travel: Not required
• Department: MMCB (Drug Product Manufacturing)
Candidate will work closely with the LSL Project User Team
Tasks & Responsibilities:
a) Tasks as MES Business Management Team:
• Implementation and validation of systems and IT processes in the manufacturing area
• Production master recipe modelling and testing including master data management
• Support by Validation activities
• Support the MES Core team
• Execution of trainings
• Close collaboration with internal and external partners like Business, Informatics, Engineering and Suppliers
b) Tasks as SPOC function:
• Creating and rephrasing of User Requirement Specifications (URS).
• Performing of Fit Gap Analyses (FGA).
• Performing of Functional Risk Assessments (FRA).
• Creating and review of testcase specifications for User Requirement Tests (UAT)
• Performing of User Requirement Tests (UAT)
• Review and approval of Functional Specification documents (FS)
• Keep in contact with other PTC sites and distribute information to them
• Degree in informatics or engineering
• 5 to 7 years of experience in Manufacturing Execution Systems (MES), PharmaSuite®
• You bring experience in specifying, configuring, testing and documenting of systems and applications
• You are self-reliant, resilient, flexible and have a high service orientation
• Good technical understanding with good networked thinking (former experience with programming would be great)
• Good communication skills (German and excellent English language skills)
Next steps: First interviews should take place in the first week of July (04.07. morning and 06.07. morning).
If you are available and interested to apply, please submit your CV for immediate consideration to Danielle@next-ventures.com