Digital Records Senior Specialist MES (Manufacturing Execution System)

Job Description

An opportunity has arisen for a Digital Records Senior Specialist to join our team at the high-tech Salamanca site, within the Digital Records Design Hub.
 

As a Digital Records Senior Specialist (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 Spanish 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.

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Current Contingent Workers apply HERE

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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:

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Travel Requi