Electronic Batch Record Specialist

Fresenius Kabi • Melrose Park, IL

23h

About The Position

The Electronic Batch Record Specialist is responsible for the maintenance, compliance, and change control of electronic batch records generated through the PAS-X system. This role involves creating Electronic Batch Record templates and Product Batch records for the Melrose Park manufacturing site. The position requires ensuring the timely generation of executable electronic batch records to the shop floor, generating and reviewing new policies and Standard Operating Procedures (SOPs), and revising existing SOPs related to Electronic Batch Records. The specialist will provide technical expertise in the design, execution, and implementation of continuous improvement activities for electronic batch records in batch manufacturing and equipment management. This includes integrating the PAS-X system with other applications like SAP and Documentum, coordinating the integration of manufacturing equipment data into PAS-X for automation, and evaluating the PAS-X system and site operations through continuous monitoring of Key Performance Indicators (KPIs). The role also involves documenting trends and findings, assisting with the identification and implementation of corrective actions, and disseminating information from other departments to ensure the department is informed to meet company goals and project timelines. Additionally, the specialist is responsible for maintaining and continuously improving the ISO 50001 energy management system, identifying energy savings opportunities, making recommendations for energy-efficient operations, and monitoring and analyzing energy consumption.

Requirements

• Bachelor’s Degree in engineering, IT, computer science or related disciplines.
• Experience with programming or configuring a work flow automation platform preferably in the pharmaceutical industry.
• Experience with manufacturing of Aseptic and Terminally Sterilized parenteral drugs.
• Experience with Databases.
• Experience with Virtual Machines.

Responsibilities

• Assures timely generation of executable electronic batch records to the shop floor through use of the PAS-X system.
• Generates and reviews new policies and Standard Operating Procedures and revises SOPs associated with the Electronic Batch Record as needed.
• Provides technical expertise in the design, execution, and implementation of continuous improvement activities relating to the Electronic Batch Records for batch manufacturing and equipment management and other Applications.
• Integrates the PAS-X system with other applications, such as SAP and Documentum.
• Coordinates the integration of Manufacturing Equipment data into the PAS-X system to ensure proper automation of documentation.
• Evaluates the PAS-X system and site operations through continuous monitoring of the system through Key Performance Indicators (KPIs).
• Documents trends and findings.
• Assists with the identification and implementation of corrective actions.
• Disseminates information from other departments in order to assure the department is properly informed to meet company goals, project timelines, etc.
• Responsible for maintaining and constant improvement of the ISO 50001 energy management system.
• Identify energy savings opportunities and make recommendations to achieve more energy efficient operation.
• Monitor and analyze energy consumption.

Benefits

• 401(k) plan with company contributions
• paid vacation
• holiday and personal days
• employee assistance program
• health benefits to include medical, prescription drug, dental and vision coverage
• life insurance
• disability
• wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level