IS Applications Analyst for Manufacturing Systems
About The Position
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease. As the IS Applications Analyst for Manufacturing Systems, you will be responsible for the management and support of Manufacturing Systems including Rockwell PharmSuite Electronic Batch Record system (eBR) and Antares Serialization System. Responsibilities will include front-line application support, project management, validation, and end-user training. In addition, the role will need to support design, implementation, and maintenance of Electronic Batch Records (eBR). This role is critical in ensuring compliance with regulatory standards, optimizing batch manufacturing processes, and enhancing data integrity. The IS Applications Analyst for Manufacturing Systems works closely with cross-functional teams to support production operations and be comfortable analyzing data and looking at opportunities to utilize AI tools to enhance processes. With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.
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.
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.
- Coordinate changes to Enterprise Resource Planning (ERP) system master data, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, and formulas.
- 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.
Benefits
- Comprehensive healthcare (medical, dental, and vision)
- 401k plan and company match
- Short and long-term disability coverage
- Basic life insurance
- Wellness benefits
- Reimbursement for certain tuition expenses
- Sick time of 1 hour per 30 hours worked
- Vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment
- 15 paid holidays per year
- Paid parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
