What are the responsibilities and job description for the Manufacturing Process Engineer position at Intellectt Inc?
Job Title: Manufacturing Process Engineer - Pharma
Location: Middletown, VA
Duration:12 Months
Job Description:
· Conduct detailed process analysis to identify areas for improvement, inefficiencies, and potential risks in the mixing of bulk pharmaceutical solutions.
· Develop and implement process flows, standard operating procedures (SOPs), and best practices to ensure optimal manufacturing performance.
· Oversee and support the bulk mixing operations of pharmaceutical solutions, ensuring that processes meet industry standards and regulatory requirements.
·Collaborate with the production team to troubleshoot and resolve process-related issues in real-time.
· Lead PFMECA efforts to assess potential risks and failure modes in bulk mixing processes, ensuring that appropriate mitigation strategies are in place to prevent process failures.
· Analyze critical points in the process to determine their impact on overall product quality and yield.
· Develop and execute process validation protocols (including IQ, OQ, PQ) to confirm that manufacturing processes meet predetermined acceptance criteria.
· Use statistical methods (such as Six Sigma, DOE) to analyze process data and implement data-driven changes.
Education:
Bachelor’s degree in Engineering (Chemical, Mechanical, or related field) or equivalent experience.
Experience:
At least 5 years of experience in the pharmaceutical industry, specifically in bulk solution mixing.
Minimum 3 years of experience as a Manufacturing Engineer focusing on bulk mixing, process validation, and risk analysis (PFMECA).
