Manufacturing Engineer — Validation & Process Optimization

EQVAL Group, Inc; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Life Insurance

PTO

Holidays

EQVAL Academy Courses

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. seeks a Manufacturing Engineer experienced in Medical Device/Pharma validation to join our on-site team in Juncos, Puerto Rico. You will lead IQ/OQ/PQ validation activities, optimize manufacturing processes and ensure regulatory compliance.

The role requires hands-on validation documentation, experience with FDA inspections and CAPA workflows, and strong MSA/DOE skills. Bilingual in English and Spanish is a plus; compensation includes benefits and growth opportunities.

Qualifications

• Bachelor's degree in Engineering required.
• Experience in Medical Device or Pharmaceutical validation.
• Hands-on experience with FDA inspections, ISO audits, change control, CAPA.

Responsibilities

• Lead and execute validation activities for equipment and processes (IQ, OQ, PQ) and related docs.
• Design and optimize manufacturing processes, layouts, material handling and tooling.
• Troubleshoot and improve production equipment to enhance efficiency and quality.
• Collaborate with cross-functional teams to investigate NCRs, complaints and implement corrective actions.
• Ensure compliance with cGMP in all processes and validation activities.

Skills

Validation IQ/OQ/PQ

GxP & cGMP

Statistical analysis

DOE

MSA

Lean Six Sigma

NCRs/CAPA

Education

Bachelor's degree in Engineering

Tools

Minitab

Job description

EQVAL Group, Inc. seeks a Manufacturing Engineer experienced in Medical Device/Pharma validation to join our on-site team in Juncos, Puerto Rico. You will lead IQ/OQ/PQ validation activities, optimize manufacturing processes and ensure regulatory compliance.

The role requires hands-on validation documentation, experience with FDA inspections and CAPA workflows, and strong MSA/DOE skills. Bilingual in English and Spanish is a plus; compensation includes benefits and growth opportunities.