Master Batch Record (MBR) Author

SimoTech requires an experienced Master Batch Record (MBR) Author for a Biotechnology project in Cork. Candidates must have at least a minimum of 3 years plus experience of Werum PAS-X or other MES platforms in a pharmaceutical/biopharmaceutical environment.

Responsibilities
  • Support of Electronic Master Batch Records in MES.
  • Author and revise applicable SOPs.
  • Develop and own required Metrics to lead improvements based off the metrics.
  • Perform other job related duties as assigned.
  • Operations of shop floor support of the Manufacturing Execution System (MES).
  • Leading and implementing the site’s MES training plan and coordinating all MES master data.
  • Daily shop floor support of the newly implemented Manufacturing Execution System.
  • Provide day-to-day support for the site’s manufacturing execution system as subject matter expert.
  • Partner with operations, educate, revise and improve site procedures to align with the MES system.
  • Coordination and implementation of the MES training plan.
  • Coordinate all MES Master Data activities between systems and ensure the systems are synchronized.
Requirements
  • A minimum of a Bachelor’s Degree in engineering.
  • A minimum of at least 3 years plus experience of Werum PAS-X or other MES platforms in a pharmaceutical/biopharmaceutical.
  • A minimum of 2 years of working in a GMP/FDA regulated environment is required.
  • SME for all matters related to MBR design and master data strategy. This will include activities such as developing a standardized approach to MBR design and master data that can be used on all sites, setting up a centralized library of re-usable MBR elements, MBR and master data management activities for the agreed core environments.
  • Have exposure to & working knowledge of electronic batch records and/or other automated processes/systems (labs).
  • Process modelling experience in the MES context.
  • Knowledge of MES integration with ERPs and automation systems.
  • Experience of developing master batch records (MBRs) to reflect the manufacturing process and master recipes.
  • Experience of weigh & dispense functionality, EBR functionality, e-log books etc.
  • Experience and ability to work in a team environment liaising with company stakeholders from various business departments.
Only Candidates eligible for work permits for Ireland/EU can be considered for this role.