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Business Systems Technology Specialist III – SAP Quality

B. Braun Medical Inc. • Bethlehem, PA
5 days ago

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:

 

This position will design, execute, deploy and support SAP technology in the area of Quality Management.  The position will work closely with Business colleagues to identify and solve system challenges related to the Quality processes involved in the production of products and materials to be used in manufacturing and sold to the customer.

 

Responsibilities: Essential Duties

 

  • Design, execute and deploy business application systems Apply technical expertise to the implementation, monitoring, or maintenance of IT systems.
  • Involvement in the planning, analysis, design, development, testing, implementation, maintenance, and management of solutions.
  • Establish a technical vision for complex, enterprise projects.
  • Interact with IT colleagues and business stakeholders in problem solving, creating business capabilities, and defining effective and efficient technology solutions for solving business problems.
  • Assist System Analysts, Network Administrators, and the helpdesk deskside support group with technical support issues.
  • Ability to present technical concepts across multiple levels of an organization.
  • Provide product focal point and subject matter technical expertise.
  • Provide escalated user support.
  • Monitor activities of and coordinates activities with service providers, partners and vendors for installation, maintenance and troubleshooting.
  • Assist Business colleagues in creation of training documentation and knowledge transfer.
  • Interacts with local and global colleagues to ensure solutions follow strategic path goals and objectives.
  • Prepare project status reports to inform management to project progression.  Identifies any issues which need to be escalated for resolution or assistance.
  • Adhere to system validation plans as required to meet corporate business needs and support the company’s GxP validation requirements. 
  •  
Additional Responsibilites:
  • Provide configuration and functional support for SAP Quality Management. This includes but is not limited to functionality and configuration experience in the areas of inspection types, digital signatures, quality notifications, inspection points, physical sampling, labeling, reporting, batch management, batch characteristics, certificates (CoC/CoA), material master data, security roles.
  • General business knowledge of Operations organization, including various types of inspections at different stages of product build, materials management, general master data across QM/PP/MM, Project management standards.
  • Lead implementation of SAP QM module functionality in the areas of Inspection Planning, Inspection processing, Procurement in Quality, Certificate of Conformance processing in existing plants as well as adding on new plants to the QM module.
  • Expertise in implementation of end-to-end processes in relation to Quality Management with specific expertise in the areas of Inbound, In Process and Outbound material inspections.
  • Working knowledge of inventory management reports, transactions, movement types and chain of custody.
  • Understanding of inspection plan, master inspection characteristics, sampling procedures, Dynamic Modification Rules, CoC, Catalogs master data, Quality Info Record.
  • Interfaces with other software, for example LIMS, EWM, MES, QM-IDI, and having IDOCs knowledge is a distinct advantage.
  • Detailed knowledge of GMP & GLP requirements, proficient in writing validation documents (functional, technical specifications), test script development and execution (IQ/OQ).
  • Generic understanding of workflow design.
  • Good Knowledge of SAP authorization roles, objects and basic reports to troubleshoot missing authorization and help security team with security design or helpdesk tickets.
  • Maintain the Subject Matter Expert (SME) training documentation tool and create new training as projects evolve.
  • Lead new technology evaluation related to operating systems, hardware, software packages, development tools and methodologies.  Identify alternative or new technologies and implement.
  • Participate on global Quality team for S/4 Hana implementation
  • Participate with global teams on international, harmonization efforts.
  • Basic knowledge of programming concepts to interact with developers
  • Manage upgrades and application of hot packs/support packages within the Quality module.
  • Adhere to project plans and schedules.  May serve as project leader and/or working participant on assigned projects.
  • Provide support to Quality production system users by phone or on site for seven days a week, 24 hour a day basis.
  • Train new and existing users on use of systems
  • S/4 Hana, EWM QM experience a plus
  •  

Expertise: Knowledge & Skills

  • Requires advanced knowledge of professional field and industry.
  • Influences the development of and drives the application of principles, theories, and concepts.
  • Determines best course of action.
  • Work under minimal supervision.
  • Relies on experience and judgement to plan and accomplish assigned goals.
  • May periodically assist in orienting, training, and/or reviewing the work of peers.
  • Judgement is required in resolving complex problems based on experience.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers.
  • Occasional contact with external contractors/vendors.

 

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.
  • Applicable industry/professional certification preferred.
  • Regular and predictable attendance
  • Occasional business travel required, Ability to work non-standard schedule as needed, 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/A

Environmental Conditions:

  • Occasionally:N/A
  • Frequently:N/A
  • Constantly:N/A

Work Environment:

 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Noise Intensity:Moderate
  • Occasionally:Other
  • Frequently:N/A
  • Constantly:Office environment

 

What We Offer

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.   Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Notices

Equal Opportunity Employer Veterans/Disabled