BD (Becton, Dickinson and Company) Quality Engineer I in Sparks, Maryland

Job Description SummaryThe Quality Engineer I is responsible for timely planning, execution, and summary of validation studies at the Media facilities as directed by the Site Validation Leader. Additional responsibilities include contributing to risk analysis and control plan implementation, and supporting efforts to improve measurement and change control systems.

Job Description

RESPONSIBILITIES:

  • Draft validation protocols including validation strategies based on critical to quality (CTQ) characteristics and process, equipment, and/or product technology

  • Perform studies as defined within validation protocols to collect data on selected processes, equipment, and/or products

  • Compile data, analyses, and documentation from validation studies and draft validation completion reports

  • Provide validation and approval status for tracking against planned goals and timelines

  • Contribute to capturing technical knowledge of critical inputs through risk analysis and control plan implementation

  • Support efforts to improve measurement reliability and sustain the validated status of equipment through change control

  • Interact with associates in Quality, Operations, Engineering, Technology, and other departments for completing aforementioned duties and responsibilities

  • Attend and successfully complete BD Validation Practitioner training

REQUIREMENTS:

  • Bachelors Degree (BA/BS) in Chemical Engineering or other engineering discipline

  • 2 years Quality Engineering experience or Masters Degree.

ADDITIONAL AND PREFERRED SKILLS AND QUALIFICATIONS

  • Previous validation experience is preferred

  • Experience or training within a Food & Drug Administration (FDA) regulated setting is helpful

  • Experience or training with Six Sigma methodology a plus

  • Candidate must be able to take the initiative to organize and complete tasks in a timely fashion

  • Candidate must possess sufficient technical aptitude to understand process and measurement equipment

  • Candidate must display an awareness of safety and quality practices

  • Some problem-solving and team participation abilities are required

  • Excellent communication and mathematical skills are required

  • Knowledge of document (Word) and spreadsheet (Excel) management software is preferred

  • Knowledge of Quality System Regulation (QSR) requirements is helpful

  • Knowledge of analytical and statistical tools and software (e.g., Minitab) is a plus

Primary Work LocationUSA MD - Baltimore

Additional Locations

Work ShiftNA (United States of America)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status