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Manager of Validation

Company: Jobot
Location: East Orange
Posted on: November 21, 2022

Job Description:

Your next career move into management awaits!
This Jobot Job is hosted by Kyle Cherry
Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.
Salary $0 - $70,000 per year
A Bit About Us
This client provides packaging solutions to leading RX, OTC and generic pharmaceutical companies.

Why join us?

We're Growing, Come Join our Success! Health/Dental/PTO/401k Match and more!
Job Details
The role
The Validation Manager will work with the engineers on the packaging line. Transfer the knowledge and understanding of equipment, electronics, and data integrity. Write validation documents for the company as well as validation documents for our customers new products.
Required Qualifications

  • Bachelor's degree in technical area
  • Experience in Quality Engineering, Control or Assurance in the nutraceutical, pharmaceutical
  • Demonstrated project management/leadership experience.
  • Experience in systems qualification/validation.
  • Experience with Six Sigma, QC/QA methodologies, tools, and processes.
  • Experience working with FDA Regulations.
  • Strong communication, organizational, teamwork, presentation, analytical, reporting and project management skills.
  • Knowledge of statistical principles and analysis and failure investigation principles.
  • Proficiency in Microsoft Office including Excel, Outlook, and PowerPoint.
  • Working knowledge of GAMP5 compliance requirements
  • Experience in overseeing and managing factory equipment calibrations
    Essential Duties And Responsibilities
    • Provide oversite of facility projects, including installation and upgrading of equipment, to ensure site is maintained in a qualified state of operation.
    • Act as a point of contact for all site qualification and validation activities including the review and approval of lifecycle documents such as IQ/OQ/PQ and validations.
    • Review requirement specifications and technical documents and provide timely and meaningful feedback.
    • Provide validation oversight of Technical Change Control for facilities and equipment changes.
    • Lead the development and implementation of site qualification and validation processes in compliance with all applicable CFR regulations.
    • Collaborate on design, development, and coordination of Quality Improvement and Performance Improvement initiatives. Interface with internal project teams and stakeholders.
    • Effectively communicate relevant project information to the Leadership Team.
    • Drive a systematic approach to problem solving and process improvement using quality management and engineering tools such as Six Sigma, DMAIC, Statistical Process Control, Design of Experiment, etc.
    • Oversee CAPAs, Deviations, IRs, and audit action follow-ups across all technical teams.
    • Assist in internal audits and external audits to support compliance.
    • Train and mentor associates in validation principles.
    • Oversee compliance to computerized systems and calibration systems for all factor
      Preferred
      • Six Sigma Black or Green belt; ASQ or PMP certification
        Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Keywords: Jobot, East Orange , Manager of Validation, Executive , East Orange, New Jersey

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