Validation Specialist -1st Shift in West Caldwell, NJ at Volt

Date Posted: 8/30/2021

Job Snapshot

Job Description

 Validation Specialist (1st Shift)

West Caldwell, NJ

Direct Hire, Salaried

Join the Quality Technical Services team at this growing Pharmaceutical company! 

Primary Job Functions:

  • Supports/Drives Process Validation Program (Process and Equipment) including Continued Process Verification (Stages 2 and 3 of 2011 FDA Guidance on Process Validation).
  • Supports/Drives Cleaning Validation and Verification Program.
  • Interacts directly with customer on deviations and cleaning and process validation strategy for assigned projects.
  • Reviews and approves batch records.
  • Reviews and validates Electronic Spreadsheets.
  • Supports Equipment Installation and Operational Qualifications.
  • Assesses regulatory impact of deviations, changes to equipment and batch records, materials, and calibrations from validation perspective.
  • Analyzes data and works with Project manager to solve technical problems.
  • Additional duties and tasks assigned at the discretion of Quality Management.

Senior Level position available too

  • Assumes supervisory role in absence of supervisor (for Sr. Level)
  • Need Extensive experience with Data Integrity Assessments and Computerized System Validations (for Sr. Level)

Qualifications/requirements: 

  • Bachelor’s degree in science
  • Minimum of 3 years in a Pharmaceutical Field or 7 years for Sr. Level
  • Experience in cleaning, manufacturing processes, equipment, and facilities validations.
  • Knowledge of pharmaceutical process and equipment
  • Knowledge of validation concepts and current cGMP (21 CFR Parts 210 & 21, 820 & Part 11). 
  • Batch records knowledge and data review experience
  • Demonstrated experience in writing and reviewing validation reports.
  • Familiarity with Change Control Processes.

VOLT is an Equal Opportunity Employer.