Process Engineer

4 days ago

Rahway, New Jersey, United States Insight Global Full time

Job Summary:

We are seeking a highly skilled Process Engineer / SME with 2+ years of experience in pharmaceutical development / manufacturing to fill this critical role.

The ideal candidate will play a key part in developing and optimizing process recipe templates, harmonizing terminology, and ensuring compliance with regulatory standards.

This position requires excellent communication and collaboration skills, a strong scientific background in drug development / manufacturing, and hands-on laboratory / shop-floor experience.

The Process Engineer / SME will work closely with cross-functional teams to ensure process designs are efficient, scalable, and compliant with regulatory requirements.

Key Responsibilities:

  • Develop, implement, and maintain general process templates for small and large molecule drug production.
  • Collaborate with R&D, quality assurance, and regulatory teams to ensure process designs align with scientific and regulatory requirements.
  • Integrate ontologies to support consistent documentation and process standardization across the organization.
  • Ensure compliance with GMP, FDA, and other regulatory standards throughout all manufacturing processes.
  • Contribute to the development of Standard Operating Procedures (SOPs) and process documentation for continuous improvement.

About Insight Global:

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal opportunity/affirmative action employer that believes everyone matters.

We are committed to providing a safe and healthy work environment for all employees.

Required Skills & Experience:

  • Bachelor's degree in Chemical Engineering, Process Engineering, or a related field.
  • 2+ years of hands-on experience in a pharmaceutical manufacturing / development environment, preferably with exposure to both small and large molecule drug production.
  • Strong understanding of drug development processes, including formulation, scale-up, and technology transfer.
  • Experience with manufacturing technologies and systems (e.g., bioreactors, batch reactors, filtration systems, distillation, chromatography, etc.).
  • Proficiency in GMP, FDA, and other regulatory requirements relevant to pharmaceutical production.
  • Experience working on the shop floor in a GMP regulated space.
  • Strong communication and collaboration skills, with the ability to work cross-functionally in a fast-paced environment.
  • Experience with process documentation, including the development of ontologies.
  • Knowledge of process validation and qualification is preferred.

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