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).