Job Summary

Seeking an experienced Sr. Manufacturing Engineer with a strong mechanical/manufacturing engineering background and hands-on experience in automated manufacturing environments, preferably within the life sciences, pharmaceutical, biotech, or medical device industry. The role involves equipment design, line optimization, process improvements, vendor coordination, and support for CQV activities.

Key Responsibilities:

• Design, develop, and optimize automated manufacturing systems.
• Create line layouts, equipment modifications, and custom fixtures using AutoCAD and SolidWorks.
• Develop URS, SOPs, work instructions, and technical documentation.
• Support equipment installation, startup, and CQV activities.
• Coordinate with automation, quality, validation, vendors, and contractors.
• Perform engineering gap assessments, risk assessments, and feasibility studies.
• Ensure compliance with cGMP, FDA, and industry standards.

Required Qualifications:

• 5–10 years of Manufacturing, Mechanical, or Process Engineering experience.
• Strong experience in automated manufacturing environments.
• Hands-on experience with equipment design, installation, modifications, and line layouts.
• Proficiency in AutoCAD and SolidWorks.
• Familiarity with PLCs and HMIs (not a controls role).
• Experience generating URS, SOPs, diagrams, and work instructions.
• Experience working in a cGMP/regulatory-compliant environment.

Preferred Qualifications

• Life sciences (Pharma, Biotech, Medical Device) experience.
• Fill-Finish manufacturing experience.
• Experience with filling, capping, and labeling equipment.
• CQV support experience as an SME.
• Project management and vendor management experience.

Education

Bachelor’s Degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline preferred.