Quality Computer Systems Engineer

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.

Position Summary:

The Quality Computer Systems Engineer will maitain and support quality analytical systems as site Administrators to maintain secure system access including but not limited to the following software or processes: Charles River Endoscan, Mettler Toledo LabX, Waters Empower, Agilent Chemstation, Shimadzu Labsolutions, Rudolph Polarimeter, Shimadzu UV-1800, Beckman Pharmspec Particle Counter, and applicable spreadsheets. They will also support the qualification of new systems and verification of test methods and procedures on new hardware or instrumentation as needed, and support the laboratory in audits, CAPAs, investigations, and other quality areas.

Responsibilities: Essential Duties

• Research, develop, and prepare new processes which support the testing of product and raw materials using newly implemented hardware and software installations.
• Support the installation and qualification of testing hardware and software including but not limited to LabX, Empower, LIMS, Lonza (WinKCL) and etc.
• Support the development and implementation of new test methods to effectively utilize quality hardware and software.
• Research and develop new processes to facilitate quality automation process both in the laboratory and production environments.
• Generate and revise procedures to align with developed processes and regulatory guidance to facilitate product quality and patient safety.
• Regularly interface with vendor installation and service personnel to ensure conformity of all hardware and software installations.
• Generate hardware and software URS, Validation protocols, and supporting data as required and GAMP.

Expertise: Knowledge & Skills

• Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
• Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of other 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.

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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Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required.
• 04-06 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Occasional business travel required, Secrecy and invention agreement and non-compete agreement, Ability to work non-standard schedule 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.

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, Visual Acuity with or without corrective lenses
• Frequently:Sit
• Constantly:N/A

Activities:

• Occasionally:Push/pull, Reaching upward and downward, Standing, Walking
• Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

• Occasionally:Proximity to moving parts
• 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:Low
• Occasionally:Other
• Frequently:Production/manufacturing environment
• Constantly:Office environment

Equal Opportunity Employer Veterans/Disabled

PI254962969