Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (e.g., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.
• Salary Range: $70,000-$85,000
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities
- Troubleshoots and supports Empower CDS, Regulatory Asset Manager (RAM), isolated networks for standalone computerized systems, the R&D ticketing system, and other standalone computerized systems, ensuring seamless operation and compliance with regulatory standards.
- Supports account management, ensuring effective data management with both automated and manual backups, maintains robust database systems, and supports IT infrastructure.
- Assists the Technical Team Lead with global Enterprise IT initiatives and enterprise system projects as necessary.
- Supports local subnetwork infrastructure for standalone systems as necessary.
- Issues licensing of all software packages within the R&D laboratories.
- Maintains the software related Service Contracts for all R&D computer systems.
- Coordinates with vendors to ensure systems are maintained and updated in a validated state.
- Maintains an inventory of all computer hardware, software and licenses.
- Responsible for disaster and recovery of all R&D software driven systems.
- Provides qualification and change control support associated with the computerized system installation, changes, and upgrades in accordance with software QA procedures.
- Generates and maintains the computerized system design specifications, and routes in document management system as necessary.
- Responsible for supporting the R&D laboratories Data Integrity program by ensuring the secure, complaint, and efficient operation of computerized laboratory systems.
- Maintains expertise in areas of responsibility through ongoing training and participating in industry associations.
- Develops and fosters ongoing relationships with critical stakeholders and throughout the company to understand the needs of the business and implement solutions
- All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, Quality Management , as per your roles and responsibilities.
Requirements
- Bachelor’s degree in technology/computer science, engineering, or science related field;
- Minimum 3 years of experience in IT related field.
- A high level of technical expertise is required in Installation of networking devices, operating systems, business applications, computer hardware, and peripheral devices.
- Working knowledge of GMP regulations and quality management systems.
- Strong knowledge of industry regulatory standards, such as ISO 17025 and FDA requirements
- Preferred experience with Java and SQL
- Skills with system security preferred
- Project management skills are preferred.
- Excellent analytical and problem-solving abilities.
- Strong written and verbal communication skills, with ability to present to stakeholders.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness 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.
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What We Do
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.
Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.
Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.
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