Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For our site in Lengnau (Bern – Switzerland) we are currently looking for a
Senior MES Engineer (f/m/d)
(Please note that this position is only available at our location in Lengnau)
The state-of-the-art multi-purpose manufacturing facility is designed for large-scale production of biologics and has high expansion potential. After completion of construction activities, our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.
Your tasks:
In project phase responsible for the implementation of Manufacturing Execution System (MES) solution – including the design, setup, commissioning, startup and the validation of the MES both software and hardware components. In operational phase for the well maintaining and functionality of the MES ensuring the Business continuity.
Key responsibilities:
- Collaboration with others departments (ex. QA, QC, Supply Chain, Manufacturing, I&T or rest of Automation) in the project and later on in routine in order to assure overall coordination of the dependencies and required exchange information for the execution of MES
- Participation to all projects (Computerized Systems) related documents (development and testing) such as qualification (DQ, IQ, OQ, PQ), requirements specifications, etc. dealing with the MES
- Support and contribute to the development of functional and detailed designs, implement and test complex MES (Siemens Opcenter Execution Pharma) solutions using both custom developed software applications and configured products that meet stakeholders’ requirements and create technical documentation to a standard required for validated facilities.
- Provide to the team manager with all necessary support and information to ensure that they are fully informed of progress.
- Assist and support stakeholders with resolving application problems and installing software upgrades as well as patches for MES systems.
- Support and contribute to the development of different Standard Operating Procedures (SOPs), Work Instruction (WI) or Guidelines for qualification and routine activities of the MES
Knowledge, Skills, Abilities
- Minimum 2 years of successful project execution and major projects for computerized systems
with high complexity and interfaces to other applications (SCADA, Manufacturing Execution System, Building Management System), biotech/pharmaceutical or other industries.
- In-depth working experience in regulated industries; knowledge of cGMP, 21 CFR part11 and validation is a plus
- Experience of integration with process automation solutions (e.g. PCS7, DeltaV)
- Experience with ERP interfacing (e.g. SAP) or other level 4 (ISA 95)
- Working knowledge of SQL Server or Oracle database
- Experience with labeling solutions for production environments
- Proven experience with end-to-end integration of stand alone equipment (e.g. Package Units)
- Knowledge of active directory – user management, DNS, IP networks and virtualization is a plus
- Proven knowledge and understanding of ISA 95 and ISA 88 standards
- Proven customer focus experiences and situational adaptability with both internal and external resources.
- Proven experience in support of multi-site projects is a plus
- Languages: English fluent in written and spoken. German is a plus
What we offer
- Employment with an innovative organization
- Outstanding career and development prospects
- Company pension scheme and other fringe benefits
- Exciting company culture which stands for integrity, intensity, involvement and innovation
If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.
Apply today! http://jobs.thermofisher.com
Agency notice!
Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.