Senior MES Engineer (m/f/d)

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.

To excel in this role, you will more than likely have the following skills:

• Bachelor’s degree in Life Science discipline or equivalent practical experience of at least 5 years of experience in MES area, PAS-X system experience preferred.

• At least 3 years of experience in Automation or Engineering function for Biologics, Food, Medical Devices, or pharmaceutical industries.

• Thorough knowledge of computer validation/SDLC requirements and change control procedures. (e.g., GAMP 5)

• Demonstrated hands-on PAS-X experience (Werum/Körber) is preferred, including Master Recipe Management, GMBR/MBR design and build, PAS-X Master Data, Weigh & Dispense, equipment tracking, and eRec/eSig paperless batch record execution.

• Proven ability of working cross functionally, delivering technical solutions for MES (PAS-X) issues.

• PAS-X 3.3.x / Core version awareness.

• Basic knowledge in batch review-by-exception concepts.

• Ability to manage multiple priorities and know when to escalate for resolution.

• Proven experience in commissioning and validation, test protocol execution (e.g., Kneat eVal), is an advantage.

• Strong problem solving and troubleshooting skills.

• Effective oral / written communication skills in English (C1)

Required Skills:

Preferred Skills:

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