We are looking for a Validation Lead who will be working for the Global Solution Center – Manufacturing IT supporting Pharma Global Technical Operations at Kaiseraugst and Basel, Switzerland.
The main focus of this position will be MES (Manufacturing Execution System). In addition there will be topics around Shop Floor Serialization, Data Analytics and Reporting Solutions.
Tasks & Responsibilities
- Leads a project stream for validation with the objective to set up the CSV of a MES Program (initial Core validation + rollouts)
- Ensures the completion of CSV deliverables in time and in quality (Ensures the alignment of the different stakeholders, Collaborates with and gives regular updates to the Project Manager
- Authors, reviews and consults on validation documentation including but not limited to Test Scripts, Validation Plans, Installation Qualifications, SATs, UATs and Validation Reports
- Ensures compliance with corporate and global pharma standards (e.g. internal CSV policies, directives and SOPs or project management methodology) and legal requirements
- Escalates non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution
- Provides advice, expertise and trains others in the requirements for Quality Assurance and provides input to Informatics process improvement projects and other cross functional programs
- Preferred start date: 04.09.2017
- Latest start date: 11.09.2017
- End date: 31.12.2018
- Work location: Kaiseraugst, Basel
- Travelling: Some travel (max. 20%) may be required (to vendors in Germany, e.g. Karlsruhe).
- Remote/Home Office: Possible max. 1 day per week, other days 100% onsite.
- Workload: 100% (potentially start with a lower workload, min. 80%, and then ramp up to 100%)
- Extension: An extension might be possible, but would need to be approved.
- Additional information: Team of ca. 20 team members.
- Department: FPPM (Pharma Informatics – Manufacturing IT)
- Very good understanding of CSV in a pharmaceutical MES (+7 years of work experience in the relevant area)
- Strong project management skills and delivery focused (+5 years of PM experience)
- Experience in validation for MES projects (+5 years of work experience)
- Ability to communicate clear and effectively
- Ability to arbitrate between a wide range of stakeholders to come to a solution (former work experience with stakeholders would be a big plus)
- Strong leadership skills (former work experience as a lead would be a big plus)
- Fluent in English (written and spoken)
- Flexible for business travels (up to 20%)
- Experience in CSV for a global program
- Understanding of the MES process
- German speaking
- pharma experience