Industrial Engineering Manager

Required

• -Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, or a related technical field.
• -5-7 years of experience working in Engineering or similar support group in regulated environments (pharmaceutical, biotech, medical device, or cleanroom facilities).
• -Working knowledge of sterile filling, tableting, liquid filling, powder blending, package handling, facility operation, and facility design.
• -Understanding of regulatory compliance requirements such as 21 CFR, EU Annex 1, and USP 797.
• -Strong analytical, problem-solving, and communication skills with the ability to work independently, across cross-functional teams and the ability to troubleshoot complex technical issues. .
• -Strong skills in process mapping, data analysis, root cause analysis, and the use of statistical tools for performance improvement. Experience with AutoCAD or other facility layout and engineering design tools.
• -Excellent cross-functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams.
• -Willingness to travel as required for vendor FATs and document punch list items for correction.
• -Hands-on experience supporting 503A and/or 503B compounding operations, with working knowledge of pharmacy regulatory standards.
• -Excellent written and verbal communication skills and the ability to work effectively across cross-functional teams.