Senior Systems Analyst, MES

BioSpace; Novato (CA); Hybrid; USD 80,000 - 100,000; Full time

Job summary

A biotechnology company in Novato is looking for a MES Senior Systems Analyst to manage and configure the MES application. This position involves user access management, validation protocol execution, and collaboration with IT. Applicants should have 3-5 years of experience in a similar role, familiarity with Körber PAS-X, and strong communication skills. The role offers a flexible work style, including some on-site work requirements.

Qualifications

• 3-5 years of industry experience with over 2 years in a similar role.
• Familiarity with the Körber PAS-X MES software.
• Ability to lead discussions and troubleshoot electronic systems.

Responsibilities

• Administer and configure the MES application.
• Manage user access and validation protocols.
• Collaborate with IT for system setup and support.

Skills

Technical writing skills

Strong technical background

Strong communication skills

Education

BA or BS in a science or engineering field

Tools

Körber PAS-X MES software

SAP S4/Hana ERP systems

Job description

The Novato MES Senior Systems Analyst is responsible for administering and configuring the MES application, managing user access, and executing validation protocols. This role involves collaborating with IT infrastructure for system setup, supporting MES infrastructure issues, and engaging with vendors for system analysis, migration, and updates.

The analyst manages interfaces between MES and other systems like SAP and LIMS, develops and executes test protocols, and leads technical support and troubleshooting efforts. Additional duties include overseeing documentation, supporting audits and inspections, leading deviation investigations, implementing application changes, and contributing to MES enhancements and project deployments.

Responsibilities

• MES application administration, user management, application configuration and execution of IQ/OQ protocols for MES System Master Data and configuration.
• Work closely with IT Infrastructure team on configuration and setup of MES infrastructure, databases and installation of Third-Party Applications. Assists IT Infrastructure team in supporting issues with MES infrastructure.
• Configuration and management of MES Level 4 Interfaces to SAP and LIMS and any other applications that are integrated with MES.
• Creation and execution of test protocols for application changes and for Level 2, Level 3 and Level 4 interfaces to MES.
• Development of test MBRs, master data and system master data to support validation testing.
• Creation and management of MES configuration documents and IT administration SOPs and work Instructions.
• Attends workshops and meetings with MES vendor for FIT Gap analysis, MES migration preparation activities, application changes or hotfixes and any other application specific activities that require vendor consultation.
• Assist with and support any site Inspections, internal audits and any queries relating to MES application.
• Participate in and support MES FAT and SAT activities onsite or at vendor site.
• Support MES Core and IT Level 4 team in troubleshooting interface issues and any application issues affecting performance and execution on the MES application by end users.
• Configuration setup and validation of Electronic Data Interchange (EDI) queries and other external data tools such as PowerBI.
• Leads technical support effort for IT related issues in the MES application and its interfaces.
• Assist and lead deviation investigations and corrective actions relating to MES application and Level 4 interfaces.
• Implement application changes and enhancements using standard BioMarin change control processes.
• Achieve project deliverables for additional MES phases and deployments working closely with other team members and with the MES vendor.
• Contributes to additional enhancements and improvements to MES application to meet business requirements or resolve application issues and end-user experience.
• Work closely with the Validation team for execution of validation protocols and test scripts.
• Monitors systems message traffic and other MES health indicators. Constructing, generating and providing reports to business partners, as required.
• Other duties, as assigned

Experience

Required Skills: 3-5 minimum years of industry experience and >2 years in a similar role. Familiarity with the Körber PAS-X MES software. Technical writing skills to author and/or edit configuration specifications or system design documentation. Strong technical background and ability to navigate IT systems and infrastructure. Ability to lead discussions and troubleshoot electronic systems and flow of information across systems. Strong communication skills

Desired Skills: 5+ desired number of years of industry experience and 3-5 years in a similar role. Familiarity with Sap S4/Hana ERP systems

Education

BA or BS in a science or engineering field (or equivalent experience)

Equipment

NA

Contacts

MES Engineers (MBR Modelers), MES Business Analyst(s), IT, Quality and Manufacturing Business Partners

Shift Details

M-F, ~0800-1700

Onsite, Remote, or Flexible

Flexible work style with a minimum of 2 days on-site during regular, non-project related, MES work. During MES project phase support, additional on-site days may be required per consultation with the Hiring Manager.

Travel Required

No regular business travel expected. Occasional trips to the BioMarin Shanbally, Ireland site may be requested.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.