Business Analyst, MESLocation Cork, Ireland Apply
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. Come join our team and make a meaningful impact on patients’ lives.
Role Summary This position will have a significant role in the delivery of MES projects and on-going support of the MES application and associated systems integrations used at the Shanbally facility.
This person will be responsible and accountable for the MES (PAS-X) in the areas of site focused user requirements, user configuration & master batch record design, application lifecycle management, system use documentation and ongoing change management efforts.
The MES Business Analyst will ensure that the system and integrations meet user requirements during Implementation and through on-going management/support.
- Work closely with the Site MES Systems Analyst to understand and ensure MES User Requirements are clear, concise and deliverable. And collaborate to troubleshoot reported problems.
- Work closely with Global MES Program team to ensure site system use aligns with global program standards
- Act as primary support for MES system application and integration transactions by providing business hours and on-call support for MES systems in coordination with super users, Automation resources, and IT personnel per defined escalation processes. Log support incidents and prepare appropriate resolution plans including deviation response as required
- Work closely with MES Business Process Owner to build system and integrations knowledge and user training. Additionally provide guidance to user community on ways MES can be used most effectively applied
- Lead process flow discussions and translate existing system functionality to future state processes, and in a way that could be understood by technical/non-technical individuals.
- Develop and maintain MES use procedures and management documentation (including standards for recipe design, master data, and integrations configurations)
- Plan, perform, and contribute expertise for MES and associated integrations lifecycle testing such as user acceptance and validation.
- Supports MES Business Process Owner in management of the MES, including providing business use expertise/knowledge of the system, administering business continuity communications & actions, and ensuring system execution continues to meet user requirements & established standards
- Responsible for continuous improvement of the MES system and associated processes and procedures
- Participation in the change control program for modifications to qualified systems. • Uses knowledge and expertise to challenge / question and coach / mentor others to do the same. • Considers global/site implications for decisions made and actions taken.
- Promotes a safety and quality compliant culture across site. • Uses cost-benefit thinking to set priorities. • Analyses tasks to identify efficiencies and ensure efforts are focused on business critical and business improvement activities. • Other duties as assigned.
- Minimum of a Computer Science, Business Information Systems or Engineering/Science Degree with minimum 8+ years’ experience in a Bio-Pharmaceutical or equivalent type life science industry.
- Post graduate qualification in BioPharma or similar manufacturing
- Experience with Manufacturing Execution systems, preferably Werum PAS|X
- Experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects
- Certification in Business or Systems Analysis (CBAP)
- Yellow/Green Belt in Lean Six Sigma
Skills & Experience Required
- Experience with Manufacturing Systems including use and support requirements
- Experience with system implementation and SDLC requirements
- Experience with the data interdependencies of integrated systems
- Knowledge of both project and GxP change control procedures incl. experience with change impact assessments
- Demonstrated strengths with trouble-shooting and resolution of technical issues and challenges
- Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements.
- Must possess a thorough understanding of current industry guidance, including GAMP 5
- Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
- Experience/Knowledge in one or more Manufacturing support systems: ERP, LIMS, EDMS, QMS, MES (pref. PAS-X).
- Proficiency with MS Office applications (Word, Excel, Visio, Project, Power Point).
- Experience with HP ALM or equivalent software testing/requirements tools
- Good verbal and written communication skills
- Good organizational skills
- Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination