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

Nerdgigs

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 in pharmaceutical operations

Job Summary

  • The Engineering Specialist leads CQV development and execution for new and modified processing equipment, systems, and critical utilities in pharmaceutical operations.
  • Joining this team offers meaningful opportunities for talent growth and to make a sustained impact on product reliability and patient safety.
  • The role supports investigations, CAPA development, audits, and regulatory inspections while ensuring adherence to Good Manufacturing Practices.

Matching Summary

The Engineering Specialist leads CQV development and execution for new and modified processing equipment, systems, and critical utilities in 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, 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)
  • CQV protocol development and execution
  • Risk-based GMP criticality assessment

Nice-to-have

  • Experience with Kneat paperless validation
  • SAP Plant Maintenance experience
  • Lean and Six Sigma continuous improvement
  • Ability to lead or facilitate small projects
  • Strong organizational and communication skills
  • Flexible support across Quality and Facilities

Key Requirements

  • Bachelor's Degree in Engineering or Science
  • Minimum 2 years qualification/validation experience
  • Knowledge of cGMP and Quality policies
  • Experience with GMP pharmaceutical manufacturing operations
  • Ability to work independently and lead tasks
  • Familiarity with regulatory requirements for CQV

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter