Sr. Specialist, Engineering (onsite)

Laboratory Animal Management Association

Rahway, New Jersey, United States
Base: $117,000.00 - $184,200.00; bonus/equity: ann...
Hybrid
Aseptic drug product formulation
Aseptic manipulations within grade a barrier isolation systems
Cgmp and safety compliance regulations
The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide

Job Summary

  • The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide.
  • As construction and commissioning and qualification of the expansion project commences, the selected candidate will contribute to equipment and facility design, system commissioning and qualification, and other critical activities necessary for facility startup and operational readiness.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Matching Summary

The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide.

Salary

Base: $117,000.00 - $184,200.00; Bonus/Equity: annual bonus and long-term incentive, if applicable; Benefits: medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

Skills & Requirements

Must-have

  • aseptic drug product formulation
  • aseptic manipulations within Grade A barrier isolation systems
  • cGMP and Safety compliance regulations
  • equipment and facility design
  • system commissioning and qualification

Nice-to-have

  • smart technologies and automated systems
  • new GMP facility startup experience
  • clinical supply chain operations knowledge
  • electronic batch record creation and execution

Key Requirements

  • 5 years of relevant experience with B.A./B.S.
  • 3 years of relevant experience with Master’s degree
  • Ability to do all required gowning and personal protective equipment
  • Ability to prepare Standard Operating Procedures and current GXP documents
  • Familiarity with United States and European Union cGMP

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter