Pharma MES Specialist (Serialization, Track/Trace, CSV, GMP, Agile, SC

RANDSTAD PROFESSIONALS is currently looking for an experienced MES SPECIALIST for a great contract in Switzerland.

The successful candidate will start in December 2017 and will get an initial 9 months contract with option for extension.

In order to be shortlisted for this role, you will have at least 3 years experience in the MES/Manufacturing IT sector in the Pharma/Healthcare/Medical Device industry. GERMAN FLUENCY is mandatory.

JOB DESCRIPTION:

- Ensure that project plans are executed according plan, on time and within budget, to achieve the business and technical objectives while following the client system development life cycle methodology, risk assessment and validation rules or compliance guidelines as needed.
- Analyzing business problems, opportunities, and challenges, factoring in a strong understanding of the technical architecture of the SERIALIZATION SOLUTION and the underlying drivers of the business associated with serialization capabilities.
- Maintaining/executing processes related to the support and service models processes belonging to the EMEA serialization standard platform. (Incl. execution and/or support of: Incident management, Change control, and Configuration management for site Schaffhausen)
- Following directions from centralized regional IT/ES (Execution System) team owing the application, support: creation of validation deliverables and SW packages to assure full compliance with quality/technical standards.
- Assure compliant project execution and documentation according to internal procedures and validation standards, (SDLC methodology, validation engineering services to ensure compliance of the EMEA solution).
- Manage communication of project status, milestones, timelines and budget to management.
- Compliance with the GMP, EHS AND SOX requirements and guidelines

BACKGROUND:

- Degree in IT or computer sciences or proven professional experience.
- 2 to 5 years' experience in IT supporting manufacturing IT systems (MES application, packaging control systems, tracking systems, and/or Printing/labeling solution
- Experience in various manufacturing automation technologies including SCADA, and/or Batch Execution Systems
- Experience with SERIALIZATION, TRACK & TRACE, PRODUCT GENEALOGY capabilities to cope with emerging market regulations.
- Specific knowledge of ANTARES TRACKING SYSTEM is a plus
- Knowledge and Experience in Agile/Scrum is a plus.
- EXPERIENCE WITH DESIGN, CONFIGURATION, TESTING, AND VALIDATION OF MANUFACTURING IT SYSTEM AND/OR PROCESS CONTROL SYSTEMS ACCORDING SDLC AND CSV METHODOLOGY
- Experience with SUPPLY CHAIN PROCESSES (PHARMA/SERIALIZATION/TRACK AND TRACE)
- Experience with industry standards such as GS1 (Global Standards organization), ISA S95 Standard for integrating shop floor to enterprise systems (Level 3&4)
- CSV: Ability to write/execute test and qualification plans
- Excellent communication skills in BOTH GERMAN AND ENGLISH

If your experience fits to the above description, feel free to send your application to (see below). All candidates matching the requirements will be contacted.

I am looking forward to hearing from you!