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

Mdcrecruiting

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, ensuring compliance with cGMP and quality standards

Job Summary

  • The Engineering Specialist leads CQV development and execution for new and modified processing equipment, ensuring compliance with cGMP and quality standards.
  • This role offers meaningful opportunities for talent growth and making a sustained impact on product reliability and patient safety.
  • The position supports continuous improvement activities and collaborates with multiple stakeholders including site business areas, equipment manufacturers, and vendors.

Matching Summary

The Engineering Specialist leads CQV development and execution for new and modified processing equipment, ensuring compliance with cGMP and quality standards.

Salary

Base: $87,300.00 - $137,400.00; Bonus/Equity: Eligible for annual bonus and long-term incentive if applicable; 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)
  • CQV protocol authoring and execution
  • Risk-based GMP criticality assessments

Nice-to-have

  • Experience with Kneat paperless validation
  • SAP Plant Maintenance experience
  • Lean, Six Sigma, and continuous improvement initiatives
  • Ability to lead or facilitate small projects
  • Strong organizational and communication skills

Key Requirements

  • Bachelor's Degree in Engineering or Science
  • Minimum 2 years qualification/validation experience
  • Experience with GMP pharmaceutical manufacturing operations
  • Familiarity with Quality, cGMP, Safety, and Environmental policies
  • Ability to work independently and lead tasks
  • Experience with oral solid dosage manufacturing preferred

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter