Validation Engineer

Manpower, Inc.; Añasco (PR); On-site; USD 32,000 - 45,000; Full time

Job summary

Manpower, Inc. is seeking a Validation Engineer in Añasco, Puerto Rico (On-Site) to join the Product Development Engineering Department supporting R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams.

The ideal candidate will have strong problem-solving skills, attention to detail, and excellent communication abilities. The role involves validating extrusion processes, contributing to NPI/NPD projects, and ensuring FDA/ISO compliant IQ/OQ/PQ validations while driving process

Qualifications

• Bachelor's Degree in Mechanical, Chemical, Polymer, Materials Engineering or related discipline.
• 2+ years of engineering experience in a regulated environment.
• Experience with validation activities including IQ/OQ/PQ.
• Knowledge of DOE, statistical analysis, and technical documentation.
• Strong troubleshooting, analytical, communication, and organizational skills.

Responsibilities

• Support validation, process development, and optimization activities for medical device extrusion processes.
• Assist with NPI and NPD projects, ensuring successful transfer from development to production.
• Execute and document process validations (IQ/OQ/PQ) in compliance with FDA and ISO requirements.
• Collaborate with cross-functional teams including R&D, Manufacturing, Quality, Regulatory, and Supply Chain.
• Collect, analyze, and interpret process data to drive quality, yield, and process improvements.

Skills

Strong problem-solving skills

Attention to detail

Excellent communication skills

Education

Bachelor's Degree in Mechanical, Chemical, Polymer, Materials Engineering

Tools

DOE (Design of Experiments)

Statistical analysis

Technical documentation

Job description

Our client, a global medical device and healthcare manufacturing leader, is seeking a Validation Engineer to join their team. As a Validation Engineer, you will be part of the Product Development Engineering Department supporting R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams. The ideal candidate will have strong problem-solving skills, attention to detail, and excellent communication skills which will align successfully in the organization.

Job Title: Validation Engineer
Location: Añasco, Puerto Rico (On-Site)
Pay Range: $28.00/hr

What's the Job?

• Support validation, process development, and optimization activities for medical device extrusion processes.
• Assist with NPI and NPD projects, ensuring successful transfer from development to production.
• Execute and document process validations (IQ/OQ/PQ) in compliance with FDA and ISO requirements.
• Collaborate with cross-functional teams including R&D, Manufacturing, Quality, Regulatory, and Supply Chain.
• Collect, analyze, and interpret process data to drive quality, yield, and process improvements.

What's Needed?

• Bachelor's Degree in Mechanical, Chemical, Polymer, Materials Engineering, or a related discipline.
• 2+ years of engineering experience in a regulated environment.
• Experience with validation activities including IQ/OQ/PQ.
• Knowledge of DOE (Design of Experiments), statistical analysis, and technical documentation.
• Strong troubleshooting, analytical, communication, and organizational skills.

What's in it for me?

• Opportunity to work with a global leader in medical device innovation.
• Exposure to NPI, NPD, validation, and process development activities.
• Experience working within highly regulated FDA and ISO environments.Competitive pay and benefits package.
• Professional growth within a collaborative engineering environment.