Senior Systems Analyst, MES
Location Novato, California Workstyle Hybrid ApplyMES SENIOR SYSTEMS ANALYST
SUMMARY
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 Interchage (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, generatingand 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 Kӧrber 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.
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
For additional benefits information, visit: https://careers.biomarin.com/benefits.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.