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

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Applied Engineering, Audit Management, Automation, Business Continuity, Business Process Improvements, Collaborative Communications, Computer Science, Data Management, Digital Manufacturing, Digital Transformation, Global Team Collaboration, GMP Compliance, Manufacturing Execution Systems (MES), Manufacturing Support, Problem Management, Process Monitoring, Quality Management, Quality Standards, Real-Time Programming, Social Collaboration, Software Development Life Cycle (SDLC), Technical Writing Documentation

 Preferred Skills:

Job Posting End Date:

07/24/2025

*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:R356634