Process Engineer
5 days ago
Job Summary:
We are seeking a highly skilled Process Engineer / Subject Matter Expert (SME) with 2+ years of experience in pharmaceutical development / manufacturing to support the development and optimization of process recipe templates and harmonization of terminology for small and large molecule drug production.
Key Responsibilities:
- Develop, implement, and maintain general process templates from scratch for the manufacturing of small and large molecule drugs.
- 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.
Requirements:
- 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.
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.
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