Duties & Responsibilities

• This role serves as SME in all ERP functionality regarding usage of XSteps, SAP Technology, SAP Master Recipes, with understanding of OMP .
• The technicality of this role assumes local and global support activities when needed.
• Supports schedule adherence for operation processes, which impact economic growth potential, reduces market risk and supports area throughput outcomes and results.
• Overseas release of Process Orders for Operations as well as the Maintenance of XSteps.
• Maintains Master Recipes in SAP including XSteps.
• Directly responsible for the expansion and development of XSteps across the organization in support of advancing and growing the business.
• Responsible for regularly coordinating and communicating with support functions such as Production Planning, Quality Assurance, Maintenance, Engineering, or other cross functional areas in support of CAPA implementation and process improvement activities and to meet product requirements and time lines.
• Leads process improvement initiatives; supports process improvement initiatives and/or project teams.
• Incorporate process improvement methodologies (i.e. 5-step method for problem solving, six sigma, lean manufacturing, etc.) in working with project teams.
• Identifies and formulates tactical solutions to assigned areas of focus.
• Supports the MBR team as the SME to ensure appropriate documentation and procedures have been followed during the production process.
• Responsible for the release of process orders within the production area.
• Responsible for CAPA implementation, auditing and revision of standard operating procedures for compliance related to production equipment and/or processes.
• Responsible for regularly coordinating and communicating with support functions such as Quality Assurance, Maintenance, Engineering, or other cross functional areas in support of CAPA implementation and process improvement activities.
• Create, review, and update OJT & MBR curricula and compliance requirements.
• Assist with planning, scheduling, and performance of job task analysis.
• Insures Regulatory Compliance regarding process order data, batch records, and correct components. Assist with change controls, BOM, routings to ensure compliance and correct costing of products.
• Ensure that SAP transactions are completed for daily process orders.
• Run reports weekly and at month end to ensure all are complete.
• Become key user for SAP and assist with training of Fill & Finish employees.
• Evaluates batch records and utilizing decision trees for releasing to appropriate resources within Fill & Finish.
• This role is critical for maintaining compliance for usage of the technologies listed above to ensure information provided to key stakeholders is accurate and to avoid risk to products and regulatory findings.

Requirements

• Bachelor´s Degree from an accredited institution in Business, Science, Biopharmaceuticals or Related Field and minimum five (5) years of production execution systems and/or material and batch record management experience in a cGMP manufacturing facility or similar production environment.
• Experience must be inclusive at least one (1) year leading moderate to complex projects and working knowledge of SAP and/or applicable systems.
• Strong decision making, communication, planning and organizing abilities are a must.
• This role requires a high degree of technical aptitude with SAP, Xsteps, and Master Batch Recipes along with local knowledge of processes and procedures and will required to support local and global activities when needed.

Desired Skills, Experience and Abilities