Engineering Specialist - Commissioning, Qualification, And Validation (cqv)

Vetamc

Rahway, NJ, US
Base: $87,300.00 - $137,400.00; bonus/equity: elig...
Hybrid
Commissioning and qualification/validation processes
Good manufacturing practices (gmp) compliance
Computerized maintenance management systems (cmms)
The Engineering Specialist leads CQV development and execution for new and modified processing equipment, systems, and critical utilities within pharmaceutical operations

Job Summary

  • The Engineering Specialist leads CQV development and execution for new and modified processing equipment, systems, and critical utilities within pharmaceutical operations.
  • Joining this team offers meaningful opportunities for Talent Growth and to make a sustained impact on product reliability and patient safety to continue advancing our mission.
  • The role supports investigations, audits, and regulatory inspections while ensuring adherence to Good Manufacturing Practices and compliance with quality standards.

Matching Summary

The Engineering Specialist leads CQV development and execution for new and modified processing equipment, systems, and critical utilities within pharmaceutical operations.

Salary

Base: $87,300.00 - $137,400.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, and sick days

Skills & Requirements

Must-have

  • Commissioning and qualification/validation processes
  • Good Manufacturing Practices (GMP) compliance
  • Computerized Maintenance Management Systems (CMMS)
  • Good Documentation Practices (GDocP)
  • Validation Master Plan development
  • Equipment commissioning and validation
  • Risk-based methodologies for GMP criticality

Nice-to-have

  • Experience with Kneat paperless validation systems
  • SAP Plant Maintenance experience
  • Lean, Six Sigma, and continuous improvement initiatives
  • Ability to lead or facilitate small projects
  • Strong organizational and communication skills
  • Independent work capability
  • Familiarity with oral solid dosage process equipment

Key Requirements

  • Bachelor's Degree in Engineering or Science
  • Minimum 2 years qualification/validation experience
  • Experience with GMP pharmaceutical manufacturing operations
  • Knowledge of cGMP policies and procedures
  • Familiarity with CMMS and CCMS systems
  • Ability to travel up to 10%
  • US and Puerto Rico residents only

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter