Digital Records Senior Specialist (f/m/d)

Merck Gruppe - MSD Sharp & Dohme; Unterschleißheim; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

A leading company seeks a skilled MES Specialist (PAS-X) to optimize their digital manufacturing processes at the Unterschleißheim site. The role involves managing the Manufacturing Execution System (MES) and supporting regulatory compliance while fostering collaboration across teams. Your fluency in German and English, combined with hands-on PAS-X expertise, will empower you to make a significant impact in a fast-paced manufacturing environment.

Leistungen

Collaborative and purpose-driven culture

Tailored development programs

Modern and inclusive work environment

Qualifikationen

• Hands-on experience with PAS-X MES; managing eBRs and recipes.
• Understanding of GMP regulations and Computer System Validation.
• Ability to communicate and collaborate effectively with cross-functional teams.

Aufgaben

• Participate in Tier meetings and resolve MES-related issues.
• Provide on-site MES support during manufacturing activities.
• Create electronic batch records and manage recipes within PAS-X.

Kenntnisse

Technical Problem Solving

Compliance & Validation

Communication & Collaboration

Ausbildung

Bachelor’s degree in Engineering, Computer Science, Life Sciences

Tools

PAS-X

Jobbeschreibung

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 BEFOREthe 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