Senior Manufacturing Engineer - Automation & Validation

Integrated Services for Productivity & Validation, Inc; Dorado (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

Integrated Services for Productivity & Validation, Inc in Dorado, PR seeks a Manufacturing/Validation Engineer with 5–7+ years in FDA-regulated environments to drive process validation and continuous improvement.

You will apply DOE, FMEA, CAPA, and statistical methods to develop new manufacturing processes, support design transfers, and lead cross-functional teams to ensure quality and compliance.

Qualifications

• Bachelor’s degree in engineering from a related technical field.
• 5–7+ years in manufacturing/validation within FDA-regulated environments.
• Strong knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices.
• Experience with automation/controls and equipment qualification.
• Experience with DOE, FMEA/PFMEA, CAPA, and statistical tools.
• Lean/Six Sigma and continuous improvement experience.
• Cross-functional leadership and strong communication skills.

Responsibilities

• Support product introductions, process scale-up, and design transfer.
• Lead validation and qualification activities for manufacturing systems.
• Ensure documentation discipline and Quality System compliance.
• Drive continuous improvement initiatives across teams.

Skills

DOE

FMEA/PFMEA

CAPA

Root cause analysis

Statistical analysis

Minitab

JMP

Lean Manufacturing

Six Sigma

Kaizen

Value stream mapping

Continuous improvement

Education

Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or related technical field

Tools

Minitab

JMP

Job description

Integrated Services for Productivity & Validation, Inc in Dorado, PR seeks a Manufacturing/Validation Engineer with 5–7+ years in FDA-regulated environments to drive process validation and continuous improvement.

You will apply DOE, FMEA, CAPA, and statistical methods to develop new manufacturing processes, support design transfers, and lead cross-functional teams to ensure quality and compliance.