Process Development Engineer - Validation & Automation

Veg Group; Dorado (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group is seeking a Process Development Engineer to support the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.

Key responsibilities include IQ/OQ/PQ activities, designing inspection systems, generating documentation, and managing projects from concept through implementation with a focus on DOE and

Qualifications

• 5-7+ years in manufacturing or quality engineering in FDA-regulated settings.
• Strong knowledge of 21 CFR Part 820, GMP, ISO 13485.
• Electrical and mechanical engineering background for automated systems.
• Experience with automation, tooling, fixtures, test methods, and equipment qualification.
• Proficiency in DOE, FMEA, CAPA, and root-cause investigation.
• Experience supporting new product introductions and process scale-up.

Responsibilities

• Support IQ/OQ/PQ activities and develop validation protocols, reports, and master validation plans.
• Design and develop in-process and receiving inspection systems for new components.
• Generate equipment documentation and manufacturing instructions.
• Manage process development projects from concept to implementation with cross-functional teams.
• Apply DOE, PFMEA, and risk analysis to optimize processes.
• Work with laser welding, heat bonding, injection molding, vision systems, and automation.

Skills

DOE

FMEA

CAPA

Root Cause Analysis

Automation/Controls

Process Qualification

Tools

Equipment Qualification

Laser Welding

Vision Systems

Job description

Validation & Engineering Group is seeking a Process Development Engineer to support the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.

Key responsibilities include IQ/OQ/PQ activities, designing inspection systems, generating documentation, and managing projects from concept through implementation with a focus on DOE and