Lead Pharmaceutical Process Engineer, Scale-Up & Innovation

Placements24

Willows (CA)

Presencial

USD 73.000 - 109.000

Jornada completa

Hace 11 días

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Ventajas ofrecidas por este puesto de trabajo

Competitive salary
Health insurance
Retirement plan
Paid time off
Relocation assistance
Training & conferences

Descripción de la vacante

Placements24 seeks a Principal Pharmaceutical Process Engineer to design, optimize, and scale complex manufacturing processes in Welkom, Free State. You will lead cross‑functional teams, mentor engineers, and ensure GMP and regulatory compliance.

You will develop PFDs/P&IDs, oversee validation activities, and drive process improvements for solid dosage, sterile products, or biologics, leveraging advanced simulation tools and SPC.

Formación

  • Advanced degree in chemical or mechanical engineering.
  • 10+ years in pharmaceutical process engineering with design, scale‑up and validation.
  • GMP/FDA/EMA knowledge and regulatory familiarity.
  • Experience with aseptic processing or biologics is a plus.
  • PE certification desirable.

Responsabilidades

  • Lead design, development, and optimization of pharmaceutical processes for dosage forms.
  • Develop PFDs and P&IDs with robust process controls.
  • Perform PHAs and embed safety in designs.
  • Oversee process validation protocols, reports, and execution.
  • Troubleshoot complex manufacturing issues and drive improvements.
  • Collaborate with vendors, QA, and manufacturing teams.
  • Mentor junior engineers and lead cross‑functional teams.
  • Ensure GMP, FDA, EMA compliance and stay current with industry practices.

Conocimientos

Cross-functional leadership
Data-driven decisions
Analytical skills
Communication skills
Problem solving
Team mentoring

Educación

Master's or Ph.D. in Chemical/Mechanical Eng

Herramientas

Process simulation software
Statistical Process Control (SPC)

Descripción del empleo

Placements24 seeks a Principal Pharmaceutical Process Engineer to design, optimize, and scale complex manufacturing processes in Welkom, Free State. You will lead cross‑functional teams, mentor engineers, and ensure GMP and regulatory compliance.

You will develop PFDs/P&IDs, oversee validation activities, and drive process improvements for solid dosage, sterile products, or biologics, leveraging advanced simulation tools and SPC.

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