On-Site Manufacturing Engineer — Med Device Validation & Optimization

EQVAL Group, Inc; Añasco (PR); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Life Insurance

PTO

Holidays

EQVAL Academy Certifications

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. in Puerto Rico seeks a Manufacturing Engineer with strong experience in medical device/pharmaceutical validation (IQ/OQ/PQ) and process optimization. The role focuses on validating equipment and processes, troubleshooting, and ensuring cGMP compliance in a fast-paced environment.

Candidate will design, optimize layouts, and collaborate across functions to support investigations (NCRs, Complaints) and CAPA. Must be fully bilingual (English/Spanish) and understand FDA/ISO audits.

Qualifications

• Bachelor’s degree in Engineering or related field and relevant validation experience.

Responsibilities

• Lead and execute validation activities for equipment and process changes (IQ/OQ/PQ).

Skills

IQ/OQ/PQ validation

Regulatory compliance

cGMP knowledge

Statistical analysis

Minitab

GR&R

DOE

MSA

CAPA

Lean Six Sigma

Bilingual EN/ES

Education

Bachelor’s degree in Engineering

Tools

Minitab

Job description

EQVAL Group, Inc. in Puerto Rico seeks a Manufacturing Engineer with strong experience in medical device/pharmaceutical validation (IQ/OQ/PQ) and process optimization. The role focuses on validating equipment and processes, troubleshooting, and ensuring cGMP compliance in a fast-paced environment.

Candidate will design, optimize layouts, and collaborate across functions to support investigations (NCRs, Complaints) and CAPA. Must be fully bilingual (English/Spanish) and understand FDA/ISO audits.