Senior MES Engineer (m/f/d)

MSD Malaysia; Schachen; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Merck & Co. Schachen site seeks a Senior MES Engineer to lead MES solution implementation (PAS-X) and cross-functional collaboration across early and late-stage pipeline. You will drive standardization, data integrity, and line-of-sight for new tech, while supporting tech transfer and regulatory readiness.

Responsibilities include maintaining MES GMBRs, integrating PAS-X with DeltaV, and enabling compliant, validated MES operations across the site.

Qualifikationen

• Experience in MES and GMP-compliant manufacturing environments.
• Strong documentation and change-control discipline.
• Proven ability to design, implement and support MES solutions.

Aufgaben

• Provide MES technical solution implementation and ongoing support.
• Coordinate PAS-X recipes and interface with site automation.
• Maintain and improve MES design standards and GMBRs.
• Support audits and regulatory inspections as MES SME.

Kenntnisse

Change Controls

Data Integrity

Deviation Management

GMP

MES

Documentation

Standards Compliance

Strategic Thinking

Technical Leadership

Technical Problem-Solving

Technical Writing

Tools

PAS-X

DeltaV

Jobbeschreibung

Job Description

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. Our site in Schachen employs a diverse group of highly skilled scientists, engineers, technicians, and process specialists from more than 15 nations and provides an important contribution to our company’s endeavor to bring new innovative medicines to patients as fast as possible, while applying highest quality standards to all activities.

The Biotech facility, at our Schachen site, is a state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Schachen Biotech provides biologics drug substance manufacturing for early-phase clinical supply and the implementation of technology innovations into the pipeline. We are currently seeking a Senior MES Engineer (m/f/d) who will provide dedicated MES technical solution implementation and support, will coordinate and prioritize maintaining and developing MES (PAS-X) recipes, maintaining and improving the existing GMBR Design Standards, supporting MES integration with the automation layer, provide expertise and technical knowledge in a cross-site and cross-functional collaboration. The Schachen site Process Automation MES team provides a strategic link between our early and late-stage pipeline and will be responsible for developing and maintaining of ‘Line of Sight’ for new technology and innovative processes. The Senior MES Engineer (m/f/d) will support and work towards simplification, standardization and continuous improvement of technical alignment and streamline of implemented MES solutions between early nodes in the network and the Schachen site. Bring energy, knowledge, innovation, and leadership to carry out the following: Inspire Diversity and Inclusion – building effective working relationships within a cross-functional team across different cultures and backgrounds. Develop and implement optimal methodologies for the management of local MES System, in compliance with company policies, quality regulations and industry norms. Provide support for Tech Transfer of Process Technologies from early-stage pipeline facilities and drive to GMP Operational Status, and support line of sight to commercial supply from MES perspective. Own and support the integration between PAS-X and the site automation layer, including DeltaV batch integration, review-by-exception data flows, and PAS-X Automation standard or approved integration patterns; support future DeltaV and PAS-X interface projects at Schachen. Support investigations by finding resolutions to MES and automation problems. Support, maintain, and develop MES GMBRs and new capabilities as required by the pipeline products. Collaborate with other technical functions to provide robust MES GMBRs and functionality that deliver reliable and sustainable performance. Prepare and perform Change Controls and ensure they are open and closed on time in compliance with required quality standards. Provide expertise and technical knowledge to technical functions on MES functionality, GMBR implementation, EBR execution topics. Performing MES administration and maintenance and ensuring the system remains in a validated state. Identify opportunities for continuous improvement in the business process flows or in the technical implementation and workflow within the MES area. Developing and updating Automation MES SOP’s, Automation MES training packages and conducting dedicated MES trainings. Support audit and regulatory inspections as MES SME; ensure ALCOA+ data-integrity principles across electronic batch records. Ensuring all documents are compliant with SDLC requirements. Any other duties assigned by the Process Automation MES Lead. Represent the Schachen Process Automation MES team within our company’s global & corporate teams.

Required Skills

• Change Controls
• Data Integrity
• Deviation Management
• Good Manufacturing Practices (GMP)
• Manufacturing Execution Systems (MES)
• Proper Documentation
• Standards Compliance
• Strategic Thinking
• Technical Leadership
• Technical Problem-Solving
• Technical Writing

Preferred Skills

• Electronic Batch Records
• PAS-X

Employment Information

• 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

Job Posting End Date: 09/19/2026 *

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.

*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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.