Senior Validation Specialist in West Caldwell, NJ at Volt

Date Posted: 6/21/2019

Job Snapshot

  • Employee Type:
    Direct Hire
  • Job Type:
  • Duration:
    N/A
  • Date Posted:
    6/21/2019
  • Job ID:
    184286
  • Pay Rate
    $83000.0 - $93000.0/Year
  • Contact Name
    Volt Branch
  • Phone
    317-685-2200

Job Description

Position: Senior Validation Specialist

Location: West Caldwell, NJ

DIRECT HIRE POSITION

Come be a part of a growing team at a leading pharmaceutical facility!  This facility develops and manufactures innovative drug delivery systems.

In this position, you will:

  • Write Validation Protocols and Reports, especially PPQ (Process Performance Qualification) related Protocols and Reports.
  • Coordinate the training for and execution of the PPQ Protocols and provide oversight and guidance during the Manufacturing, Fabrication and Testing of PPQ Batches.
  • Champion CPV (Continued Process Verification) program to assure processes remain in a state of control.
  • Plan and coordinate cleaning and  other manufacturing processes validation activities including risk analyses and FMEAs
  • Interact directly with customer on validation strategy for assigned projects and represent Validation in project meetings.
  • Support roll out of companywide harmonized Site Validation Master Plan.
  • Assess and approve deviations, changes to equipment and batch records for validation impact.
  • Support data analysis and work with Tech Transfer Project manager to solve technical problems during development and/or scale up efforts
  • Review/approve master batch records, equipment, facility, calibration and maintenance SOP’s.
  • Review/ approve equipment, facilities and instruments related qualification documentation.
  • Ensure the program to periodically assess the qualification status of equipments/ instrumentation remains in a state of control.
  • Assume supervisory role in absence of Manager.

QUALIFICATIONS/REQUIREMENTS: 

  • BS in Scientific discipline or equivalent.
  • Previous Pharmaceutical Industry background
  • 3 years’ experience in cleaning, manufacturing processes, equipment and facilities validations.
  • Knowledge of validation concepts and current cGMP (21 CFR Parts 210/211 & Part 11, ICH)
  • Experience in data compilation and review for statistical evaluation.
  • Demonstrated experience in writing and reviewing validation reports.
  • Strong computer and interpersonal skills.

This position reports to the QTS Senior Manager

Please apply or contact Matt Haltom at (317) 599-4898 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.

Volt is an Equal Opportunity Employer