Electronic Batch Record Specialist

The position is responsible for maintenance, compliance and change control of the electronic batch records generated through the PAS-X system. In this capacity, Electronic Batch Record Designer is responsible for creating Electronic Batch Record templates and Product Batch records for the Melrose Park manufacturing site., * 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.

Do you have experience in Virtualization tools?, * 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.

Salary: Starting annual salary from $70,000 to $85,000.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage., We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.