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  • Emplois similaires à : Manager, Regulatory Clinical Trial Authorization (CTA)
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MES Deployment Support SpecialistITech Consult AG • Zug, Zug, Switzerland
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MES Deployment Support Specialist

ITech Consult AG
  • CH
    Zug, Zug, Switzerland
  • CH
    Zug, Zug, Switzerland
Postuler Maintenant

À propos

MES Deployment Support Specialist
MSAT Engineer Process Management: Process and Product Development / Gxp / Compliance & Quality / Root Cause Analysis / German/ English
Background:
As an MSAT Engineer, you will have a direct impact on and bring value to our patients and customers. Supported by your squad and chapter team, you will start with core compliance tasks-such as non- conformity, change, and document management and continuously grow in your role, taking on increased responsibility for products and processes.
For our team in Rotkreuz, we are looking for an experienced engineer to provide technical support for our existing production in daily business as well as for improvement projects within a matrix structure. If you have a background in a regulated environment, a knack for compliance, a big-picture mindset, and thrive in a fast-paced, agile environment where no two days are the same, you will fit right in!
The Perfect Candidate:
The perfect candidate is a proactive engineer or natural scientist with experience in a highly regulated, GxP-compliant environment and a strong command of both English and German (B2+). They possess a data-driven mindset capable of managing deviations, optimizing production processes, and utilizing SAP to handle non-conformities and quality lifecycles. Ultimately, they are a collaborative, hands-on problem solver who can independently manage stakeholder relationships, maintain technical supplier connections, and ensure complete audit readiness.
Tasks & Responsibilities:
• Compliance & Quality Lifecycle: Manage non-conformities, changes, and documentation in SAP (covering processes, methods, materials, and equipment)
• Manage technical relationships with external suppliers and collaborate closely with internal departments-including Logistics, Development, and Quality-to ensure a seamless product supply
• Root Cause Analysis: Enact structured problem-solving processes to ensure fact-based, data- driven root cause analysis and identify effective countermeasures
• Deviation Management: Support the investigation and processing of deviations within the S&C sensors and reagents production
• Process Optimization: Adopt and optimize production processes to improve quality, increase yield, and lower costs for your respective products
• Control Loops: Establish, maintain, and continuously improve control loops
• Stakeholder Management: Independently communicate with and gather crucial information from various cross-functional stakeholders
• Regulatory Compliance: Ensure strict adherence to existing frameworks, regulatory guidelines, and department-specific requirements.
• Audit Readiness: Prepare for quality audits and successfully represent the Chapter during audit procedures
Must Haves:
• Education: A University degree in Natural Sciences or Engineering (e.g., Biotechnology, Biology, Chemistry, Material Science, Mechanical/Electrical Engineering) and/or a completed apprenticeship with equivalent professional experience in a related field
• Experience & Mindset: First proven professional experience within a highly regulated environment, backed by a strong quality awareness (GxP mindset)
• Essential knowledge in process and product development
• Collaboration: High motivation for teamwork, excellent communication skills, and the ability to work independently within and across multi-disciplinary teams
• Proactivity: Enthusiasm for taking on responsibility and proactively collaborating with a highly engaged team of engineers, operators, QA, and logistics
• Hands-on Approach: A genuine interest in learning manufacturing technologies and continuously improving diverse BG&E processes to support our in-house production efficiently
• Languages: Fluent communication skills in English and a good working knowledge of German (B2+)
Reference Nr.:
Rolle: MSAT Engineer Process Management
Industrie: Pharma
Location: Rotkreuz
Pensum: 100%
Start: ()
Duration: 12+ months
Deadline:
If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs(at)itcag(dot)com.
Contact us for more information about our company, our positions, or our attractive payroll-only program: .
About us:
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services. jid ws jit0522ws jiy26ws
  • Zug, Zug, Switzerland

Compétences linguistiques

  • English
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