Sr Manufacturing Engineer

Job Title:
Sr Manufacturing Engineer
Job

Location:

Fort Worth, TX (100% Onsite)
Duration: 12 Months
Pay Rate: $55-60/hr on W2

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