Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Validation Engineer

Expired Job

BD (Becton, Dickinson And Company) Columbus , NE 68601

Posted 3 months ago

Job Description: Summary

Job Description

Validation Engineer JG3

ESSENTIAL FUNCTIONS

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

RESPONSIBILITIES

  • 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.

DELIVERABLES

  • 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.

Minimum Education

Bachelor's degree in Engineering, Quality Assurance, Mathematics/Statustics or Science related field

Minimum Experience

  • 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)

Additional Locations

Work Shift


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Mold Tooling Engineer

BD (Becton, Dickinson And Company)

Posted 1 week ago

VIEW JOBS 12/3/2018 12:00:00 AM 2019-03-03T00:00 Job Description SummaryNew BD state of the art injection molding facility starting up in Columbus, NE to manufacture medical devices. BD has a number of injection molding sites located worldwide. This site will be the Center of Excellence of injection molding for one of the largest injection molding companies in the world. Factory of the future technologies employed at the Center of Excellence will include all electric injection molding presses, automatic resin handling systems, in-mold sensor technology, robotic part removal, automated component handling and inspection and automated mold changes. This is an opportunity for highly motivated, forward thinking, self-starters to join this world class organization. The Mold Tooling Engineer will facilitate the fabrication of injection molding tools for plastic injection molding. This position will include vendor selection, conceptual design of tooling, selection of hot runner system, project management of tooling fabrication, and implementation of tooling into the manufacturing processes. Ensures compliance with BD quality systems, policies, procedures and best practices and all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read, write and converse in English. Job Description * Work with mold build vendors in the design of injection molding tools, to include pilot through high cavitation production, for plastic injection molding of high precision, tight tolerance plastic parts and design fixtures and jigs. * Oversee tooling projects from conception through production start-up. * Work with tooling suppliers on request for quotation, schedules, mold design reviews, hot runner system selection, mold factory acceptance test (FAT) and project implementation. * Review product designs and make recommendations on tooling projects to ensure they are designed for manufacturability, efficiency, and cost-savings. * Participate in tool design reviews and ensure they are conducted in accordance with the BD guidelines and adhere to the BD mold design and build standards. * Evaluate part design for manufacturability using Mold Flow Analysis to evaluate mold filling, mold cooling and warpage analysis, and in molded stress analysis. Work with mechanical engineering to optimize part design. * Oversee all record retention for tooling. This will include required follow-up on action items resulting from preliminary mold designs through production startups. This encompasses both internally designed and built tooling along with all sub-contracted work. * Monitor construction of injection molds. * Source tooling suppliers and interact with them on regular basis to ensure that services meet expectations. * Monitor project schedules with tooling suppliers and ensure that projects are completed on time and according to design requirements * Implement tooling modifications and improvements. * Work with reverse engineering principles and rapid prototype resources as needed. * Utilize basic understanding of dimensioning, tolerance and inspection practices. * Coordinate and control all cost, delivery and quality objectives for the design, construction and validation of assigned injection mold projects. * Other duties as assigned. QUALIFICATIONS AND REQUIREMENTS Minimum Education and Experience: This position has the following educational requirements: Required: Associate's Degree Field(s) of Study: Business, Engineering, Plastics or related discipline with 3-5 yrs. experience. Preferred: Bachelor's Degree Field(s) of Study: Plastics Engineering or related Engineering field with 2 yrs. experience. Minimum Knowledge, Skills, or Abilities (KSA's): Basic or Simple KSA: Project management of tooling fabrication Proficient / Working KSA: 3D modeling software/Solidworks; Computer Skills (Microsoft Office) Advanced or Specialized KSA: Problem solving/decision making; Oral and written communication skills. 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. #LI-OPS Primary Work LocationUSA NE - Columbus (East) Additional Locations Work Shift BD (Becton, Dickinson And Company) Columbus NE

Validation Engineer

Expired Job

BD (Becton, Dickinson And Company)