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Job Description
Summary:
We are seeking a highly skilled and motivated Process Engineer / Subject Matter Expert (SME) with 2+ years of Drug Substance / Drug Product experience in pharmaceutical development / manufacturing to join our team. The ideal candidate will play a critical role in the development and optimization of process recipe templates, and harmonization of terminology , for both small and large molecule drug production. This position requires excellent communication and relationship building skills, a strong scientific background in drug development / manufacturing with hands-on laboratory / shop-floor experience, and an enthusiasm for learning new software tools. The Process Engineer / SME will collaborate closely with cross-functional teams, ensuring that process designs are efficient, scalable, and compliant with regulatory standards.
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.
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. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
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Skills and Requirements
Bachelors degree in Chemical Engineering, Process Engineering, or a related field.
Ability to build general process templates, sometimes from scratch
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. null
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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.