MES Integration
- Central Germany
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing nearly 200 different medicines and vaccines healthcare products to help improve the lives of millions of people in the UK and around the world every year.
Our purpose is grounded in our belief that all people deserve to live healthy lives. This drives our desire to provide medicines that are safe and effective.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Responsible for providing technical guidance and support in the execution and delivery of the Manufacturing Execution System (MES).
- Coordinate and align within the Global MES team and other IT teams involved as well as with the customers.
- Strong experience with MES systems
- Analysis and solving of technical issues related to the MES system and/or interfaces Direct and manage activities of technical staff on URS/FRS generation, software configuration and coding.
- A thorough understanding of system cGMP requirements and demonstrable knowledge of computer system design and maintenance lifecycle in cGMP environments.
- Liaise where necessary with MES platform provider, engineering contractor, and equipment vendors on the lifecycle of document preparation, approval, coding, and delivery.
- Assist with Computer Systems Validation (CSV) activities: Validation Plan, Risk Assessment, Protocols, Test Protocols, Change Requests etc.
- General management and oversight to the MES software documentation effort
Desirable Experience:
- Bachelor’s Degree in Engineering/ Technology or equivalent experience.
- A minimum of 3-5 years related work experience with factory automation and equipment integration within the pharmaceutical sector.
- Previous project management experience
- Substantial experience with design and operation of Biopharmaceutical facilities, both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories).
- Significant experience with MES systems desirable.
- A thorough understanding of system cGMP requirements and demonstrable knowledge of computer system design and maintenance lifecycle in cGMP environments.
- Passionate about improving the quality of software products.
- Significant experience with MES systems desirable, preferably Siemens OpsCenter
- Experience with MES integration other Applications (ERP, preferably SAP) and Laboratory Information Management Systems (LIMS) systems/ Historians OSISoft PI
- Understanding of system hardware design for PCS and MES
- Team player with exceptional customer service skills, integrity and ability to interact with all levels of personnel.
- Requires strong attention to detail and analytical skills as well as problem analysis and resolution.
- Ability to evaluate solutions and recommend action based on meeting scope, schedule, and budget
- Fluent in German
If this role is of interest to you, please apply now!
#LI-BP1
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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Ben
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