Job Description: Summary
Validation Engineer JG3
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
Assures manufacturing and support areas are compliant to regulations, standards, and internal procedures.
Provide regular updates to management of trends
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.
Process and product improvements approved by validation processes.
Global and plant validation programs meet business and customer requirements.
Change management process complies with business, customer and regulatory requirements.
Risk management process complies with business, customer and regulatory requirements.
Bachelor's degree in Engineering, Quality Assurance, Mathematics/Statustics or Science related field
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
Minimum Knowledge, Skills, or Abilities
Proficient with Validation (developing, approving, compiling) Programs, Statistical analysis skills, Team building skills, Communication skills, Problem Solving Skills. Basic knowlege of Quality systems (cGMPs and ISO)
Primary Work LocationUSA NE - Columbus (East)
BD (Becton, Dickinson And Company)