QA Validation Specialist III

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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 QA Validation Specialist III will work with the QA Validation team. In this position the individual will be responsible for supporting Engineering and Quality for new equipment, software or processes or modifications to existing equipment, software or processes on site. 

Responsibilities: Essential Duties

  • Executes qualification and validation in compliance to regulatory requirements by/with/as carry out qualification and validation according to the Validation Program.
  • Use test equipment, instruments and methods to produce data for engineering studies and validations.
  • Perform data analysis using statistical methods as appropriate to produce conclusions and recommendations for relevant work activities.
  • Preparation and maintenance of qualifications and validations documentation.
  • Handling/maintenance/calibration measuring devices used for validation for its compliance.
  • Document root cause and corrective/preventive actions of gap found during validation activities.
  • Support Pharma/Med Device Engineering projects.
  • In process/equipment in production trial/test run for machines/process to establish process parameter.
  • Process/quality improvement.
  • Support Management/Superior in qualification and validation activities.
  • When necessary, provide validation documentation for change control evidence.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

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.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training , assigning and checking the work of lower level employees. Referring only complex problems and issues
  • 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.

Expertise: Qualifications – Experience/Training/Education

Required:

  • Bachelor’s degree required, Master’s degree preferred
  • 04-06 years related experience required.
  • Occasional business travel required, Ability to work non-stand schedule as needed

Preferred:

  • Applicable industry/professional certification preferred.

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.

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.

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
  • Frequently: Stand
  • Constantly: Sit

Activities:

  • Occasionally: Finger feeling, Hearing – ordinary, fine distinction, loud (hearing protection required), Push/pull, Reaching upward and downward, Stooping/squatting
  • Frequently: Standing
  • Constantly: Sitting

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: Moderate
  • Occasionally: Production/manufacturing environment
  • Frequently: N/A
  • Constantly: Office environment

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