Sr. Specialist, Engineering (onsite)

539

Rahway, New Jersey, United States
Base: $117,000.00 - $184,200.00; bonus/equity: eli...
Hybrid
Aseptic drug product formulation
Aseptic manipulations within grade a barrier
Cgmp and safety compliance regulations
The FLEx Sterile Expansion Project aims to more than double the capacity of the existing FLEx Sterile Facility by adding new suites and supporting infrastructure

Job Summary

  • The FLEx Sterile Expansion Project aims to more than double the capacity of the existing FLEx Sterile Facility by adding new suites and supporting infrastructure.
  • This role involves collaborating with diverse stakeholders to drive design, risk assessments, strategic planning, and ensure successful project C&Q and startup phases.
  • Upon operational commencement, the individual will partner with teams to ensure the quality of clinical supplies and enable flexibility and speed of the company's sterile pipeline.

Matching Summary

The FLEx Sterile Expansion Project aims to more than double the capacity of the existing FLEx Sterile Facility by adding new suites and supporting infrastructure.

Salary

Base: $117,000.00 - $184,200.00; Bonus/Equity: eligible for annual bonus and long-term incentive; Benefits: medical, dental, vision, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Must-have

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

Nice-to-have

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

Key Requirements

  • B.A./B.S. with 5 years relevant experience or Master's with 3 years relevant experience
  • Ability to do required gowning and PPE
  • Prepare Standard Operating Procedures and GXP documents
  • Familiarity with US and EU cGMP

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter