Sterile Specialist, Engineering (onsite)

Muckelab

Rahway, NJ, US
Base: $87,300.00 - $137,400.00; bonus/equity: elig...
Hybrid
Sterile drug product manufacturing equipment
Gmp and safety compliance
Equipment troubleshooting mechanical/electrical/automation
This role supports the formulation and filling of clinical, stability, and developmental supplies for sterile products, ensuring equipment reliability and compliance with GMP and Safety requirements

Job Summary

  • This role supports the formulation and filling of clinical, stability, and developmental supplies for sterile products, ensuring equipment reliability and compliance with GMP and Safety requirements.
  • The successful candidate will manage equipment validation lifecycles, coordinate maintenance and capital projects, and act as a Subject Matter Expert for sterile validation programs.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, vacation, and sick days.

Matching Summary

This role supports the formulation and filling of clinical, stability, and developmental supplies for sterile products, ensuring equipment reliability and compliance with GMP and Safety requirements.

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

  • Sterile Drug Product manufacturing equipment
  • GMP and Safety compliance
  • Equipment troubleshooting mechanical/electrical/automation
  • Computerized Maintenance and Management Systems
  • Quality Engineering support
  • Capital project management
  • Validation of sterilization and cleaning equipment

Nice-to-have

  • Independent problem-solving
  • Effective communication and technical writing
  • Organizational skills
  • SAP Plant Maintenance experience
  • Experience with electronic validation systems
  • Planning and scheduling practices
  • Business and financial practices knowledge

Key Requirements

  • Bachelor's degree in engineering or science
  • Minimum 2 years related Drug Product/Sterile/Validation experience
  • Familiarity with cGMP and Quality policies
  • Experience with SAP Plant Maintenance
  • Ability to work 2nd shift
  • US and Puerto Rico residents only

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter