IS Applications Analyst for Manufacturing Systems

Responsibilities

• Provide technical and functional support for Manufacturing applications including Rockwell PharmaSuite EBR, Antares Serialization, along with associated hardware such as tablets, printers, and scanners.
• Design and configure MES eBR systems based on business requirements to digitize and automate batch record management, ensuring compliance with industry regulations (e.g., FDA's 21 CFR Part 11).
• Create, manage, and maintain electronic batch records, including recipe management, process steps, electronic signatures, and data capture.
• Oversee -User -Acceptance Testing of MES recipes to ensure business requirements are achieved.
• Plan and execute validation tests (IQ, OQ, PQ) to demonstrate compliance with regulatory requirements.
• Provide training to personnel on how to use eBR and Antares Serialization systems effectively.
• Analyze batch data and historical records to identify trends, deviations, and opportunities for process improvement.
• Maintain comprehensive documentation of system configurations, validation records, and standard operating procedures (SOPs) related to MES eBR systems.
• Develop system technical documentation, including but not limited to, functional specifications and UAT test scripts.
• Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to gather information and resolve discrepancies.
• Maintain data integrity by implementing periodic system reviews and audit trails for manufacturing systems.
• Identify opportunities for process improvements or automation utilizing IT systems.
• Maintain ThinManager or VDI for deploying software such as eBR.
• Authoring QMS records including deviations, CAPAs (Corrective and Preventative Actions), and change controls.
• Co-ordinate with Product Vendor in presenting incidents and follow-up in getting solutions.

Requirements

• Bachelor’s degree in relevant field (computer science, chemical engineering, or pharmaceutical sciences)
• Minimum 5 years of experience in Pharmaceuticals Industry.
• Certificate/ASC/ BS in science-related discipline preferred.
• Proficiency in MES eBR software platforms, preferably in Rockwell Automation PharmaSuite.
• Knowledge of data integrity principles and strategies to prevent data corruption and maintain data accuracy and consistency.
• Strong understanding of regulatory requirements in industries with batch processes, including FDA regulations (e.g., 21 CFR Part 11).
• Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to ensure compliance.
• Excellent communication skills to collaborate with cross-functional teams, and auditors.
• Ability to manage eBR projects, including planning, execution, validation, and documentation.
• Attention to detail and strong data-entry skills.
• Strong organizational skills and ability to manage multiple tasks and priorities.
• Proficiency in Microsoft Office Suite (Word, Excel) or equivalent software.