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Process Engineer
1 month ago
We are seeking a highly skilled Process Engineer to join our team. The ideal candidate will play a critical role in the development and optimization of process recipe templates for both small and large molecule drug production.
Key Responsibilities:
Develop and implement 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.
What We Offer:
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching.
Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Equal Opportunity Employer:
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.
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