We are currently looking for an experienced MES Specialist (PAS-X) to join our Digital Manufacturing Team at our Unterschleißheim (USH) site near Munich. If you're passionate about digital process optimization, fluent in both German and English, and bring hands-on PAS-X authoring expertise, we'd love to meet you.
About the Role
As a Digital Records Senior Specialist (f/m/d) MES, you will play a critical role in maintaining, supporting, and optimizing our Manufacturing Execution System (MES) - with a specific focus on PAS-X. You will be involved in all aspects of MES administration, recipe development, and on-floor support, helping ensure compliant, reliable, and efficient manufacturing performance.
This role requires strong technical expertise in MES environments, hands-on experience in PAS-X authoring and administration, and the ability to collaborate effectively across teams. Your work will directly support both daily operations and long-term digital transformation initiatives in a regulated, fast-paced manufacturing setting.
Tasks and responsibilities include, but are not limited to:
* Tier Process Engagement
Participate actively in daily Tier meetings to monitor production operations, proactively resolve MES-related technical issues, and ensure business continuity.
* On-Floor Support & System Administration
Provide on-site MES support during manufacturing activities; ensure that PAS-X components are properly maintained, validated, and aligned with quality standards.
* PAS-X Recipe Development
Create and manage electronic batch records (eBRs) and recipes within PAS-X, ensuring that processes are scalable, compliant, and optimized for performance.
* Vendor Management & Issue Resolution
Collaborate with external vendors to ensure service quality; support technical investigations, deviation analysis, and timely problem resolution.
* Methodology & Compliance
Develop and implement robust methods for managing MES systems in line with internal SOPs and industry standards (e.g., GMP, SDLC). Maintain audit readiness.
* Training & Documentation
Deliver MES training for relevant teams; author and update technical documentation, including SOPs and user manuals, ensuring alignment with validation protocols.
* Continuous Improvement
Identify system gaps and process inefficiencies; lead or support initiatives to improve MES usability, system performance, and cross-functional workflows.
Your profile:
* Education & Technical Expertise
Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field. Equivalent practical experience will also be considered.
* MES Proficiency (PAS-X a must)
Strong hands-on experience with PAS-X MES - including authoring and modifying MES recipes and batch records. Experience in pharma or biotech environments is highly preferred.
* Compliance & Validation
Solid understanding of GMP regulations, GAMP5, and Computer System Validation (CSV) principles. Experience with SDLC processes and audit preparation is essential.
* Technical Problem Solving
Proven ability to identify, analyze, and resolve MES-related issues in a structured and efficient manner, often under time pressure.
* Communication & Collaboration
Strong interpersonal skills, able to communicate clearly with colleagues from IT, QA, production, and external vendors. Customer- and solution-focused mindset.
* Language Skills
Fluency in German and English (written and spoken) is mandatory.
* Additional Advantage
Knowledge of Lean Six Sigma methodologies, experience with system integrations, and prior exposure to global pharma manufacturing environments.
What We Offer
* An impactful role in a company that improves lives every day
* The opportunity to work with a global team of experts on cutting-edge digital manufacturing solutions
* A collaborative, respectful, and purpose-driven culture
* Tailored development programs and career progression paths
* A modern, inclusive, and flexible work environment
Ready to make a meaningful impact in digital manufacturing? We look forward to your application.
Please note: This role includes regular on-site engagement and interaction with shopfloor teams and systems.