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  • Emplois similaires à : Application Support Analyst, Manufacturing Systems
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IS Applications Analyst for Manufacturing SystemsFerring Holding SA • Parsippany, New Jersey, United States
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IS Applications Analyst for Manufacturing Systems

Ferring Holding SA
  • US
    Parsippany, New Jersey, United States
  • US
    Parsippany, New Jersey, United States
Postuler Maintenant

À propos

Task Overview Ferring, a privately‑owned biopharmaceutical company, is seeking an IS Applications Analyst for Manufacturing Systems. The role is responsible for managing and supporting manufacturing systems, including Rockwell PharmSuite Electronic Batch Record (eBR) and Antares Serialization System, ensuring regulatory compliance, optimizing batch manufacturing processes, and enhancing data integrity. Responsibilities Provide technical and functional support for Manufacturing applications and associated hardware (tablets, printers, scanners). Design and configure MES eBR systems based on business requirements to digitize and automate batch record management. Create, manage, and maintain electronic batch records, including recipe management, process steps, electronic signatures, and data capture. Oversee User Acceptance Testing (UAT) of MES recipes to ensure business requirements are met. Plan and execute validation tests (IQ, OQ, PQ) to demonstrate compliance with regulatory requirements. Provide training to personnel on eBR and Antares Serialization systems. Analyze batch data and historical records to identify trends, deviations, and opportunities for process improvement. Coordinate changes to ERP system master data, including items, specifications, look‑ups, recipes, routings, and formulas. Maintain documentation of system configurations, validation records, and SOPs related to MES eBR systems. Develop functional specifications and UAT test scripts. Collaborate with manufacturing, quality assurance, and regulatory affairs to resolve discrepancies. Maintain data integrity through periodic system reviews and audit trails. Identify opportunities for process improvements or automation utilizing IT systems. Maintain ThinManager or VDI for deploying software such as eBR. Author QMS records including deviations, CAPAs, and change controls. Coordinate with product vendors on incident resolution and solution follow‑up. Requirements Bachelor’s degree in a relevant field (computer science, chemical engineering, pharmaceutical sciences) or equivalent experience. Minimum 5 years of experience in the pharmaceutical industry. Proficiency in MES eBR software platforms, preferably Rockwell Automation PharmaSuite. Knowledge of data integrity principles and strategies. Strong understanding of FDA regulations (e.g., 21 CFR Part 11) and GMP/GDP 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, strong data entry skills, and organizational ability to manage multiple tasks. Proficiency in Microsoft Office Suite (Word, Excel) or equivalent software. Physical Requirements Ability to move around the manufacturing plant, including walking, standing, and sitting for extended periods; occasional bending, stooping, or kneeling; repetitive keyboarding and mouse use; occasional lifting of up to 25 pounds; exposure to noise, dust, chemicals, or varying temperatures; use of personal protective equipment (PPE) as required. Benefits Competitive base salary ($76,831 – $105,000) plus annual incentive bonus. Comprehensive medical, dental, and vision coverage; 401(k) plan with company match. Short‑ and long‑term disability coverage, basic life insurance, and wellness benefits. Tuition reimbursement, sick time (1 hour per 30 hours worked), vacation (up to 160 hours in the fifth year), and 15 paid holidays. Paid parental leave (subject to minimum employment period). Location Parsippany, New Jersey. Equal Opportunity Ferring is an equal opportunity employer. All aspects of employment are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity, or veteran status.
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  • Parsippany, New Jersey, United States

Compétences linguistiques

  • English
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