Operations Technology MES Systems Analyst

Description

Corporate Statement:

Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company’s longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust.

Job Purpose: 

We are looking for a results-oriented MES Systems Analyst who is responsible for the administration, configuration, support, validation, and continuous improvement of the Manufacturing Execution System (MES) environment, with a primary focus on Rockwell PharmaSuite. This role works closely with Manufacturing, Quality Assurance, Engineering, Validation, Supply Chain, and Technology teams to ensure MES solutions support compliant, efficient, and reliable pharmaceutical manufacturing operations.

The MES Systems Analyst is a technical and business resource for electronic batch records (EBR), manufacturing workflows, recipe management, system integrations, and data integrity initiatives while ensuring compliance with GMP, FDA, and global regulatory requirements. Our preferred candidates will have a proven track record of working within a team environment to successfully address technical issues as well as great analytical and problem-solving skills, and demonstrated success with respect to problem solving and solution implementation. High initiative, attention to detail and experience in a service driven, dynamic environment is essential.

This is an excellent opportunity to jump into development and tech support in an environment with fantastic on-the-job learning, mentorship, and great growth opportunity, but any industry certifications are an asset.

Our Technology Support team is responsible for maintaining user uptime through remote monitoring and maintenance, trouble-shooting and problem resolution, and sustaining a positive organizational image through exceptional customer service.

Essential Duties and Responsibilities: 

· Administer, maintain, and support the Rockwell PharmaSuite MES platform.

· Monitor MES system performance, availability, and reliability.

· Troubleshoot and resolve MES-related incidents, deviations, and production issues.

· Manage system configurations, master data, security roles, and user access controls.

· Coordinate software updates, patches, and system lifecycle activities

· Configure and maintain electronic batch records (EBRs), workflows, recipes, and manufacturing process models.

· Design and implement MES enhancements that improve manufacturing efficiency, quality, and compliance.

· Develop and maintain equipment models, materials definitions, production workflows, and process parameters.

· Support deployment of new products, processes, and manufacturing lines within PharmaSuite.

· Support integration between PharmaSuite and enterprise systems including ERP, LIMS, SCADA, historians, and automation platforms.

· Collaborate with automation and Technology teams to troubleshoot interface and data exchange issues.

· Ensure accurate and reliable transfer of manufacturing and quality data between systems

· Identify opportunities to improve manufacturing processes through MES functionality and automation.

· Develop metrics and reporting tools that enhance operational visibility and manufacturing performance.

· Support digital transformation initiatives and paperless manufacturing strategies.

· Participate in cross-functional projects focused on operational excellence and manufacturing modernization.

· Provide MES technical support to manufacturing, quality, and engineering personnel.

· Develop and maintain MES training materials and procedures.

· Train end users on MES functionality and best practices.

· Serve as a subject matter expert for PharmaSuite-related processes and technologies.

Knowledge & Skills: 

· Knowledge of FDA 21 CFR Part 11, Data Integrity, GAMP 5, and GMP regulations.

· Strong troubleshooting, analytical, and problem-solving skills.

· Excellent written and verbal communication skills.

· Experience with Rockwell PharmaSuite implementation, administration, or development.

· Experience integrating MES with ERP systems such as SAP, NetSuite, or Oracle.

· Knowledge of PLC, SCADA, and industrial automation systems.

· Experience with SQL databases, reporting tools, and data analytics.

· Familiarity with serialization, genealogy, track-and-trace, or manufacturing intelligence systems.

· Certification in Rockwell Automation technologies or related manufacturing preferred

Education/Experience: 

· Bachelor's degree in Engineering, Computer Science, Information Systems, Biotechnology, Pharmaceutical Sciences, or related field preferred.

· Minimum 3–5 years of experience supporting Manufacturing Execution Systems in a regulated manufacturing environment.

· Hands-on experience with Rockwell PharmaSuite or comparable MES platforms.

· Experience with pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing operations.

· Strong understanding of manufacturing processes, batch execution, and electronic batch records.

· Experience supporting validated systems and computer system validation activities.

Working Conditions / Physical Requirements:

• This      position requires bending, typing, lifting (up to 40 1bs.), standing,      sitting and walking throughout the facility