Manager of Validation
Location: East Orange
Posted on: November 21, 2022
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
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.
- Bachelor's degree in technical area
- Experience in Quality Engineering, Control or Assurance in the
- Demonstrated project management/leadership experience.
- Experience in systems qualification/validation.
- Experience with Six Sigma, QC/QA methodologies, tools, and
- Experience working with FDA Regulations.
- Strong communication, organizational, teamwork, presentation,
analytical, reporting and project management skills.
- Knowledge of statistical principles and analysis and failure
- Proficiency in Microsoft Office including Excel, Outlook, and
- Working knowledge of GAMP5 compliance requirements
- Experience in overseeing and managing factory equipment
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
- 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
- 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
- Oversee CAPAs, Deviations, IRs, and audit action follow-ups
across all technical teams.
- Assist in internal audits and external audits to support
- Train and mentor associates in validation principles.
- Oversee compliance to computerized systems and calibration
systems for all factor
- Six Sigma Black or Green belt; ASQ or PMP certification
Interested in hearing more? Easy Apply now by clicking the "Apply"
Keywords: Jobot, East Orange , Manager of Validation, Executive , East Orange, New Jersey
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