Job Description
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.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Required Skills:
Applied Engineering, Audit Management, Automation, Business Process Improvements, Communication, Computer-Aided Manufacturing (CAM), Data Management, Detail-Oriented, Digital Manufacturing, Engineering Mathematics, Ethical Decision Making, Manufacturing Execution Systems (MES), Problem Management, Quality Management, Real-Time Programming, Regulatory Compliance, Regulatory Requirements, Software Development Life Cycle (SDLC), Technical Issues, Technical Problem-Solving, Technical Solution Development, Technical Solutions
Preferred Skills:
Job Posting End Date:
07/31/2025
- A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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