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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.
Job 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 is a plus.
Experience with Databases is a plus.
Experience with Virtual Machines is a plus.
Basic knowledge of Networks and Servers is a plus.
A familiarity with Microsoft based applications.
Excellent verbal and written communication skills required
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.
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.
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, disabilities, or protected veteran status.