Sr Manufacturing Engineer

Sr Manufacturing Engineer

Seeking a Sr Manufacturing Engineer with strong experience in process validation, equipment qualification, and manufacturing process design within a highly regulated industry/medical device environment.

Key Responsibilities:

• Lead equipment qualification activities including IQ, OQ, and PQ
• Support full process validation lifecycle from process characterization through PQ
• Design and improve manufacturing processes, production layouts, and system integrations
• Develop and execute validation protocols and documentation
• Support SOP development, change control, and compliance activities
• Perform troubleshooting, root cause analysis, and process improvements
• Ensure compliance with FDA and quality system requirements

Must Have

Skills:

• Equipment IQ/OQ/PQ experience
• Process validation lifecycle experience
• Manufacturing process design and system integration
• DOE/Minitab experience preferred
• Project management skills
• Experience in regulated manufacturing environments

Nice to Have:

• Computer System Validation (CSV)
• SOP development
• Medical device change control experience

Qualifications:

• Bachelor's degree in Mechanical Engineering or related discipline
• 5+ years of manufacturing engineering experience in regulated industries