Columbus, NE, USA | Becton Dickinson & Company
Job Description:92 people have viewed this job
The Validation Engineer acts as a key resource for driving continuous improvement through the validation process. This position is responsible for writing technical validation protocols and reports, risk management (FMEA) documents, and change control documents for the plant.
Additional responsibilities include:
• Writing procedures and supporting the document handling system
• Training associates.
• Assures manufacturing and support areas are compliant to regulations, standards, and internal procedures.
• Provide regular updates to management of trends
• Interacts with internal business process areas, multiple BD plants, corporate and worldwide with emphasis on validation and quality improvement programs
Regular, punctual attendance is an essential job function. Ability to speak, read and write English. Ensures compliance with BD quality systems, policies, procedures and practices and all local, state, federal and BD safety regulations, policies and procedures.
Write protocols and reports to ensure compliance to the Validation Master Plan, the Validation Procedure and the BDX Validation Toolkit. Performs statistical analysis using tools such as: descriptive statistics, measurement system analysis, hypothesis testing, designed experimentation, control chart theory, acceptance sampling, etc. Prioritize projects to meet validation schedule with engineering and operations. Assume a role of leadership in analyzing and resolving issues which are affecting or potentially could affect successful validations. Ensure validation support structure and document handling system are developed and maintained Host training and educational sessions appropriate for associates relevant to validation procedures. Local Implementation of Validation Toolkit Track and report monthly metrics related to the validation program. Assist with the management of the plant change control program including review and approval of change requests to ensure compliance with Change Control Procedures. Be familiar with plant and worldwide goals related to quality, validation, risk management and change control. Other duties as assigned.
- Bachelor's Degree Required in Engineering, Quality Assurance, Science, or Math discipline
- 2-3 years’ experience in process validations – writing protocols, performing validations and compiling final reports.
- Proven history of product / process improvements utilizing Statistical techniques
- Ability to generate validation protocols of process equipment that utilize process controls to meet quality requirements.
- Process validation training and experience
- 2-3 years’ experience with SAP is preferred
- Experience in plastic molding and/or liquid silicon rubber
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.
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