Description

The Operations Specialist is responsible for creating detailed production schedules, department documentation flow, SAP and inventory department functions. These functions include, but not limited to: equipment ordering lists, production schedule flow charts, preparing batch record documentation packets, OJT documentation flow, equipment log books, organizing / archival of applicable business function documents, compliance systems, inventory control and SAP department functions. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Create production schedules and/or applicable metrics / data to reflect production planning requests. Manage schedule updates based on production / equipment issues and changes. Identify and resolve production bottlenecks and equipment conflicts.
• Create and manage department equipment, media and solution schedules with other departments / vendors that supply consumables to support operations.
• Independently prepare documentation batch record packets and preparation of MBP's. Review / organize and ensure timely documentation flow.
• Assist in the creation, review and approval of relevant SOP's, controlled forms and other business functions documents to support regulatory compliance, change controls and company driven initiatives.
• Coordination of inventory cycle counts. Identify and resolve inventory discrepancies. Inventory lead for annual audits.
• Subject matter expert in SAP. Ensures end of month and timely transactions of production batches.

Requirements

• Bachelor's Degree in Microbiology, Biology or related scientific field from an accredited institution.
• A minimum two (2) years of experience in cGMP Bio manufacturing, pharmaceutical or similar manufacturing environment or five (5) years of experience supporting relevant production processes in a cGMP manufacturing facility or similar environment in lieu of degree.
• SAP Key User Certification preferred.
• Bio-manufacturing and/or cGMP regulated industry experience is preferred.
• Must be proficient in MS office applications including Word, Excel, Outlook, etc.

Desired Skills, Experience and Abilities

PDN-9d53a436-0a6c-472d-ba0b-b5f3613c27a7