B. Braun Medical, Inc.  B. Braun Medical, Inc.   IT Validation Specialist I  US-PA-Bethlehem  Job ID: 2023-23602 Type: Hybrid Full Time 

　　of Openings: 1 Category: Information Technology B. Braun Medical Inc.  Overview   

　　About B. Braun 

　　B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®. 

　　Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com. 

　　Responsibilities   

　　Position Summary: 

　　Responsibilities: Essential Duties 

　　• Creates computer system validation (CSV) deliverables (Validation Plans, Requirements, Design Specs, Test Scripts (IQ / OQ / PQ), Summary Reports, Trace Matrices, SOPs, Risk assessments). Implements validation plans and protocols based on system understanding and analysis of functional and system specifications to ensure new and changes to GxP software / computer systems are maintained in a state of control. Ensures compliance with company policies and consistent interpretation and implementation of regulatory controls and industry best practices (e.g., FDA 21 CFR Part 11, new pronouncement, predicate rules, validation and risk-based understanding, ALCOA). 

　　• Collaborates with business users, IT personnel, Global IT teams and Business Analysts to define validation 

　　• requirements and plans. 

　　• Ensures accuracy and completeness of Software Development Lifecycle records. 

　　• Maps test cases to user requirements to ensure complete test coverage. Reviews and pre-execution approves GxP relevant test cases for accuracy and effectiveness to test objectives. 

　　• Review executed acceptance, general system, stress and stability testing for completeness and ensure good 

　　• documentation processes are followed. 

　　• Oversees the IT change management process, including governance and prompt completion of requests. 

　　• Reviews executed test documents and attached evidence to ensure stated criteria is adequately met; provide IT 

　　• QA approval/ review to test documentation and change controls to proceed with change or implementation activities. 

　　• Ensures test case failures or bugs are adequately investigated, logged and resolved. 

　　• Provides feedback in the review of all deliverables across the IT infrastructure, systems and applications lifecycle,ranging from requirements documentation to design, ensuring compliance with IT standards and company guidelines/policy. 

　　• Participates in process improvement efforts of computer system policies, procedures and computer system validation processes. 

　　Expertise: Knowledge & Skills 

　　• Requires advanced knowledge of professional field and industry. 

　　• Influences the development of and drives the application of principles, theories, concepts. Determines best course of action. 

　　• Provides direct or indirect supervision to a group of employees, assigning tasks and checking work at frequent intervals. 

　　• Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions. 

　　• Judgement is required in resolving complex problems based on experience. 

　　• Contacts are primarily with department sup rvisors, leads, subordinates, and peers. 

　　• Occasional contact with external contractors/vendors. 

　　The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate. 

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　　Target Based Range  $84,390 - $105,490  Qualifications   

　　Expertise: Qualifications -Education/Experience/Training/Etc 

　　Required: 

　　• Bachelor's degree required or equivalent combination of education and experience. 

　　• 08-10 years related experience required. 

　　• Regular and predictable attendance 

　　• Occasional business travel required, On-call hours as needed 

　　While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. 

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　　Additional Information   

　　Responsibilities: Other Duties: 

　　The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. 

　　Physical Demands: 

　　While performing the duties of this job, the employee is expected to: 

　　• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. 

　　Lifting, Carrying, Pushing, Pulling and Reaching: 

　　• Occasionally:Reaching upward and downward, Push/pull, Stand 

　　• Frequently:Sit 

　　• Constantly:N/A 

　　Activities: 

　　• Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking 

　　• Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick 

　　• Constantly:N/