Recipe Modeler, 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.
The Manufacturing Execution System (MES) Recipe Modeler will initially work within the MES project team to facilitate development and delivery of MES (PAS|X) master batch records (recipes) and master data required for system implementation. This includes establishing associated procedural documentation and change management.
This person will be responsible for on-going (post-project) recipe and master data creation and maintenance including maintaining the associated procedural documentation, and conducting ongoing change management and reporting activities.
The MES Recipe Modeler will develop sufficient knowledge of system and end user requirements to ensure that the system recipes and master data are optimized to meet system, end user and integration requirements.
Responsibilities include but are not limited to the following:
- Work collaboratively with MES project implementation team to ensure delivery of system recipes and master data in alignment with the project implementation plan.
- Participate in the development and maintenance of the MES recipes’ GMP validation lifecycle documentation.
- Create and maintain MES recipes and master data through lifecycle. Recipe types include master batch records, generic master batch records, and equipment recipes. Master data includes MES equipment masters and integrated master data such as with ERP.
- Act as a line of contact/escalation point in the support model 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.
- Create and maintain procedures pertaining to the GMP lifecycle of both recipes and master data.
- Create and maintain recipe parameter value lists and integration configuration values.
- Partner with Process Execution Teams to prioritize and implement MES recipe and master data modifications to improve quality and operational effectiveness.
- Provide feedback to Technical Operations on optimal Master Recipe design associated with new product transfer and equipment/process changes proposed.
- Manage recipe approval processes and lead MES recipe approval change control activities
- Maintain recipe, master data, and integration configuration design in alignment with established site and global MES standards
- Complete or participate in investigations (Events/CAPA's) for deviations related to MES recipes, master data, and integration configurations
- Participate in compliance inspections for topics related to MES system recipes or master data
- Work across platforms with other Recipe Management Specialists, to manage and develop site recipes
- Support development and testing activities related to recipe and master data setup
- Develop and cultivate technical expertise and knowledge within the site and across the MES global community by disseminating best practices and sharing knowledge across functions.
- Implement best practices to create competitive advantage for the site and coordinates tasks to ensure timely delivery
- Ultimately lead the management of MES recipe and master data change requests and perform training, coaching, and business-as-usual duties as required.
- Work collaboratively with key users to improve and maintain high master data accuracy. And monitor key recipe and master data performance indicators to meet strategic goals
- Generate reports to support key stakeholders within the business to review master data, effectively develop new recipes, or update recipe templates
- 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 4+ years’ experience in a Bio-Pharmaceutical or equivalent type life science industry.
- Experience with Manufacturing Execution Systems (pref. Werum PAS|X)
- Experience with MES Recipe and master data development and management
- Knowledge and understanding of ERP data requirements related to supply chain and/or manufacturing
- Automation (pref. DeltaV) and PLC production system experience
- Experience in the pharmaceutical or biotechnology industry, particularly within Manufacturing or Manufacturing support functions
- Demonstrated strengths in the areas of technology along with attention to detail
- Experience with User-based systems, with some understanding of set-up, technical configurations and data management
- Knowledge and understanding of MES recipe and master data (or batch record) development practices and change control principles.
- Experience with, or at least knowledge of, the data interdependencies of integrated systems
- An understanding of GxPs, and/or computer validation and Part 11 / Annex 11 requirements.
- Good verbal and written communication skills.
- Good organizational skills.
- Must have great interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination.
- Proficiency with MS Office applications (Word, Excel, Visio, Power Point).
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.