This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Job DescriptionAn 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 EngagementParticipate actively in daily Tier meetings to monitor production operations, proactively resolve MES-related technical issues, and ensure business continuity.On-Floor Support & System AdministrationProvide on-site MES support during manufacturing activities;
ensure that PAS-X components are properly maintained, validated, and aligned with quality standards.PAS-X Recipe DevelopmentCreate and manage electronic batch records (eBRs) and recipes within PAS-X, ensuring that processes are scalable, compliant, and optimized for performance.Vendor Management & Issue ResolutionCollaborate with external vendors to ensure service quality;
support technical investigations, deviation analysis, and timely problem resolution.Methodology & ComplianceDevelop and implement robust methods for managing MES systems in line with internal SOPs and industry standards (e.G., GMP, SDLC). Maintain audit readiness.Training & DocumentationDeliver MES training for relevant teams;
author and update technical documentation, including SOPs and user manuals, ensuring alignment with validation protocols.Continuous ImprovementIdentify system gaps and process inefficiencies;
lead or support initiatives to improve MES usability, system performance, and cross-functional workflows.Your profile:
Education & Technical ExpertiseBachelor'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 & ValidationSolid understanding of GMP regulations, GAMP5, and Computer System Validation (CSV) principles. Experience with SDLC processes and audit preparation is essential.Technical Problem SolvingProven ability to identify, analyze, and resolve MES-related issues in a structured and efficient manner, often under time pressure.Communication & CollaborationStrong interpersonal skills, able to communicate clearly with colleagues from IT, QA, production, and external vendors. Customer- and solution-focused mindset.Language SkillsFluency in Spanish and English (written and spoken) is mandatory.Additional AdvantageKnowledge of Lean Six Sigma methodologies, experience with system integrations, and prior exposure to global pharma manufacturing environments.Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read CarefullyMerck & 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#LI-DNI