Process Development Engineer

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

Current job opportunities are posted here as they become available.

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Process Development Engineer

Description

The Process Development Engineer supports 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.

Requirements

• 5-7+ years in manufacturing engineering or quality engineering within an FDA-regulated environment (medical devices, pharma, diagnostics, biotech).
• Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.
• Electrical and mechanical engineering background applied to automated manufacturing systems.
• Experience with automation/controls, tooling, fixtures, test method development, 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 and process performance qualification activities; develop validation protocols, reports, and master validation plans.
• Design and develop in-process and receiving inspection systems for new components and processes.
• Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.
• Manage process development projects from concept through implementation; collaborate with cross-functional teams.
• Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.
• Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.