IT Manufacturing Systems Specialist - MES, Packaging, Tracking

IT Manufacturing Systems Specialist - MES, Packaging, Tracking, Printing/Labeling, SCADA, BES

IMPORTANT:- Please note that fluency in BOTH English and German is required.

Leading global pharmaceutical client require an IT Manufacturing Systems expert on a long-term contract involving several project streams.

Job description

* Play a key role of moderate, to high complexity projects, ensuring that project plans are executed according plan, on time and within budget, to achieve the business and technical objectives while following 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.
* Assist multiple sites both in case of application issues and during installations. Provide support to the local business and/or technical resources incl. knowledge transfer and ad hoc needs
* Maintaining and executing processes related to the support and service models assuring adherence to centralized support model and problem management processes belonging to the EMEA serialization standard platform. That will include the execution and/or support of: Incident management, Change control, and Configuration management for site Schaffhausen.
* Partnering within a global Matrix organization to successfully achieve business goals. He/She will develop networks with internal and external IT and Business partners and proactively manages sites expectations
* Following directions from centralized regional IT/ES (Execution System) team which owns the application, He/She will collaborate with and at the Vendor(s) to support: creation of validation deliverables and SW packages to assure full compliance with quality and technical standards. In particular, the individual will need to diligently work proactively with the Vendor challenging technical choices during development phase to prevent issues during execution phase.
* Applying Agile methodology
* Assure compliant project execution and documentation according to procedures and validation standards, eg SDLC methodology. He/she will provide validation engineering services to ensure compliance of the EMEA solution including: Creating and reviewing Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise and executes tests to release the application both at Regional and local level.
* Assure harmonized approach within the sites and compliance to Regional/Global procedures/standards
* Manage communication of project status, milestones, timelines and budget to management. Bi-directionally, from global team(s) to the site(s) and vice versa, and timely communicate and manage escalations of issues and eventual obstacles due to potential drifting from global, common standard processes, procedures and requirements
* Work with business partners and site IT manager to identify improvement initiatives
* Work with our strategic partners (internal and external) to meet or exceed SLA's that are committed to the business for support services.
* Compliance with the GMP, EHS and SOX requirements and guidelines which are connected to the respective function

Profile

* Degree in information technology or computer sciences or proven professional experience.
* Minimum 2 to 5 years' experience in information technology supporting manufacturing IT systems. May include MES application, packaging control systems, tracking systems, and/or Printing/labeling solutions
* Experience and knowledge in various manufacturing automation technologies including SCADA, and/or Batch Execution Systems
* Understanding of various technologies used to manage and deliver serialization, track & trace, and/or 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
* Strong understanding of supply chain processes is required with specific background from the pharmaceutical sector including knowledge of serialization and track and trace capabilities required for meeting general regulations
* Experience with industry standards such as GS1 (Global Standards organization) is preferred
* Knowledge and understanding of ISA S95 Standard for integrating shop floor to enterprise systems (Level 3&4)
* Experience and knowledge in computer system validation. Ability to write and execute test and qualification plans.
* People Management experience and capabilities to include leading teams for global deployments and support of global business solutions
* Ability to work independently and proactively being focused to deliver high performance and value to the business
* Motivated self-starter capable to work on multiple simultaneous tasks with limited supervision
* Structured and systematic with strong analytical and problem-solving skill
* Excellent customer service, interpersonal, communication and team collaboration skills
* PMI and/or ITIL certification is an asset.
* Ability to communicate effectively with all levels and functional areas of business partners is required
* Fluent in German and English (spoken and written)

Please apply now for more details!