Digital Records Senior Specialist (f/m/d)

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.

Requisition ID: R354527