BD (Becton, Dickinson and Company) Validation/Quality Engineer in Holdrege, Nebraska
Job Description SummaryThis position is responsible for quality support of new product development activities, maintenance of the site validation process. Additional responsibilities include cross functional support for the Quality Engineering and Quality Systems group as well as active participation in preparation and conduction of FDA, ISO or other 3rd party Audits.
This position is also responsible for validation and GMP/Compliance Training within the plant in conjunction with the Quality Systems and Quality Engineering Leaders. This position is responsible to build sound technical and organizational competence within area of responsibility. Ensure the systems comply with applicable government regulations and standards. Comply with all BD quality policies, procedures and practices through consistent application of sound quality engineering/assurance principles.
Support the platform team on assigned new product initiatives with technical expertise and determine associated resource needs to accomplish project goals.
Maintain the Master validation Plans and validation tracking schedule.
Provide visibility via data transfer to the Business United related to all validation activities.
Support and influence change management within the plant: liaison between the core team, unit program managers, and unit quality.
Conduct training relevant to validation process and procedures.
Provide quality engineering support for material review board as required.
Approve protocols and reports for all validation activities to ensure compliance to established procedures.
Participate in the Business Unit Validation Team Meetings as required.
Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.
Provide leadership and function as a respondent during FDA, ISO, Corporate or other 3rd party audits.
Maintain alignment to BD quality policies, procedures and practices through consistent application of sound quality assurance principles.
Build interactive working and strategic relationships between BD Holdrege manufacturing, business and corporate quality management and other staff. REQUIREMENTS
Bachelors Degree. (Engineering, Biological or Physical Science strongly preferred, but will consider other degrees)
3+ years Quality experience including Validation and Quality Engineering responsibilities.
Demonstrated success with statistical problem solving/decision making. ADDITIONAL AND PREFERRED SKILLS AND QUALIFICATIONS
Six Sigma Black Belt certification desired
ASQ CQE desired
Demonstrated Quality Engineering knowledge
Excellent knowledge of the philosophy and principles of quality engineering and quality management as relates to Validation.
Demonstrated problem solving and decision making skills.
Strong understanding of failure analysis, test method validation and engineering tolerances.
Broad knowledge of manufacturing operations and quality system practices.
Strong verbal, written and interpersonal listening skills with track record of successful project management.
Demonstrated regulatory audit facing experience.
Excellent knowledge of Minitab or other statistical software, MS Word, Excel and MS Project.
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
Primary Work LocationUSA NE - Holdrege
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, or any other protected status.