Process Development Engineer – FDA-Regulated Manufacturing

Integrated Services for Productivity & Validation, Inc; Dorado (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading provider of manufacturing solutions is seeking a Process Development Engineering contractor in Dorado, Puerto Rico. The successful candidate will support the development, validation, and implementation of manufacturing processes. Responsibilities include process qualification activities and collaboration with cross-functional teams. Applicants should have 5–7+ years of experience in an FDA-regulated environment and strong knowledge of relevant regulations. This position offers a chance to work with advanced technologies in a crucial industry.

Qualifications

• 5–7+ years in manufacturing engineering or quality engineering within an FDA-regulated environment.
• 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.
• Design and develop in-process and receiving inspection systems.
• Generate equipment documentation and manufacturing instructions.
• Manage process development projects from concept through implementation.
• Apply DOE, PFMEA, and risk analysis to optimize manufacturing processes.
• Work with technologies such as laser welding and automation.

Skills

Manufacturing engineering

Quality engineering

GMP knowledge

Automation/controls

Root-cause investigation

Job description

A leading provider of manufacturing solutions is seeking a Process Development Engineering contractor in Dorado, Puerto Rico. The successful candidate will support the development, validation, and implementation of manufacturing processes. Responsibilities include process qualification activities and collaboration with cross-functional teams. Applicants should have 5–7+ years of experience in an FDA-regulated environment and strong knowledge of relevant regulations. This position offers a chance to work with advanced technologies in a crucial industry.