Senior Systems Analyst, LIMS
B. Braun Medical Inc.
Requisition ID 2017-11025
Company B. Braun Medical Inc
# of Openings 1
Job Locations US-PA-Bethlehem
Category Information Technology
Position Type Regular Full-Time
Shift 8 am to 5 pm
Site Corporate/Sales/ B. Braun of Canada/ BIS/ CeGat
Overview
With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.
U.S. Facilities and Operations:
Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.
Responsibilities
Position Summary:
A Senior Systems Analyst for LIMS will design, analyze, implement and support the LIMS computer systems and solutions based on the business requirements defined within our organization. Develops and maintains essential procedures and processes for supporting systems of medium to high complexity. The Senior Systems Analyst for LIMS is responsible for ensuring that the laboratory systems are implemented and maintained in a state of compliance, meeting current regulatory expectations and in accordance with industry best practices.
Responsibilities: Essential Duties
- Perform system analysis which includes completing requirement definitions, interfacing with business groups and providing cost and benefit analysis.
- Participate and lead new technology evaluations related to Laboratory informatics systems, hardware, management tools and methodologies. Identify alternative or new laboratory informatics technologies and assist in defining new global and regional standards.
- Manage the projects for implementation of new functionality or system upgrades.
- Maintain LIMS knowledge, including staying current on LIMS software capabilities and availability of new functionality and updates from the software vendor.
- Apply LIMS updates, submit product support requests, and perform system maintenance
- Point of contact for technical support; ensure accuracy and completeness of data and implement improvements; establish and maintain security and integrity controls.
- Proficiency in LIMS with making and testing configuration changes on the test system before applying them to the productions system.
- Maintain familiarity with QC Lab industry best practices and company specific change control SOPs.
- Complete LIMS systems administration and management training to assure understanding of technology and techniques required to implement and support a LIMS system.
- Create and revise LIMS procedures and documentation. Support required change control(s) and the business in the creation and updating of training materials as per system change(s).
- Interface with internal customer teams required for the successful deployment and maintenance of LIMS System (validation, Instrumentation experts, etc.).
- Support the infrastructure used to deploy the Enterprise Laboratory Platform (ELP) and ELP (i.e. LIMS, ELN, LabStation, etc.) components and document site specific use of the deployed ELP system.
- Engage and work with LIMS software vendors and/or consultants to further configure the system, deploy functional enhancements, and correct configuration issues.
- Support LIMS in the creation, validation, maintenance of reports, calculations, and queries as well as in the definition, approval, and validation of new business requirements.
- Responsible for the master data management process including the updating of specifications and supporting the approval process.
- Provide incident diagnosis and support business users in the management and timely resolution of technical incidents through the standard incident and problem management
- Develop and document standard work processes for LIMS training and work closely with
- Troubleshoot, identify problems, and provide advice to assist system users on course of action(s) needed through standard scripts/checklists.
- Communicate to the site any specific issues that affect users on a large scale.
Expertise: Knowledge & Skills
- Accuracy – Ability to perform work accurately and thoroughly.
- Analytical Skills – Ability to use thinking and reasoning to solve a problem.
- Communication, Oral & Written – Ability to communicate effectively with others using the spoken word and in composing clear and concise messages
- Conceptual Thinking – Ability to think in terms of abstract ideas.
- Customer Oriented – Ability to take care of the customers' needs while following company procedures.
- Decision Making – Ability to make decisions for a course of action to be taken to address a specific issue.
- Detail Oriented – Ability to pay attention to the minute details of a project or task.
- Organized – Possessing the trait of being organized or following a systematic method of performing a task.
- Problem Solving – Ability to solve problems by weighing all the variables to come up with a resolution
Qualifications
Required:
- B.S in Scientific discipline and Information Technology
- 10+ years of laboratory experience in medical device and /or pharmaceutical with a background in QC and/or Analytical Chemistry
- Minimum of 8+ years experience in LIMS administration or a similar system administration work.
- 5+ years experience in a quality role required
- Experience partnering with cross functional departments
- Experience in building, configuration, implementation, and administration LIMS systems.
- Ability to use sound scientific judgment in management of the facility to prevent regulatory action
- Ability to understand and evaluate end-to-end value streams (R&D, supply chain, product realization, PLM)
- Demonstrated track record in working with a diverse staff and establishing a clear, strategic direction.
- Ability to proactively identify and anticipate risk of non-compliance in a dynamic environment.
- To keep abreast of changes in the regulations, interpretation of the regulations, and revising internal practices, and written procedures to comply with the regulatory requirements.
Desired:
- LabWare LIMS Experience Preferred
- Project Management experience, including project initiation, team development, and achieving desired results on time and on budget.
- Experience with GMP including US and EU regulations.
- Extensive experience in evaluating and implementing computer systems.
- Project leadership and systems analysis, including cost and benefit analysis.
- Familiar with current data integrity expectations, 21CFR Part 11
- 5 – 10 years related experience
- Advanced Degree (M.S., M.B.A)
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.
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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Other
Responsibilities: Other Duties:
- Travel to any B. Braun facilities, domestic and internationally, when necessary
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:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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. The noise level in the work environment is usually moderate.
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