Manufacturing Process Engineer
5 days ago
Job Summary:
The Manufacturing Process Engineer will play a critical role in the design, optimization, and continuous refinement of processes in a pharmaceutical production setting. This exciting position is responsible for ensuring manufacturing processes comply with quality, safety, and regulatory standards, while maximizing both efficiency and reliability. The successful candidate will engage closely with cross-functional teams to troubleshoot challenges, implement improvements, and support technology transfer and scaling activities.
Responsibilities:
- Develop, optimize, and validate manufacturing processes to guarantee consistent product quality and adherence to cGMP standards.
- Lead investigations into process inefficiencies and implement corrective and preventive actions (CAPAs).
- Facilitate technology transfer, scaling, and new product introduction initiatives.
- Analyze process data to identify trends and propose actionable process improvements.
- Collaborate with Quality, Validation, and Production teams to ensure seamless manufacturing operations.
- Contribute to the authoring and reviewing of technical documentation, such as SOPs, batch records, and validation protocols.
- Uphold safety, environmental, and regulatory compliance standards.
Qualifications:
- Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering, or a related discipline.
- A minimum of 3 years of experience in a pharmaceutical manufacturing environment.
- Strong understanding of cGMP regulations, process validation, and compliance standards.
- Familiarity with process modeling, data analysis, and continuous improvement methodologies (e.g., Lean, Six Sigma) is preferred.
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