Senior Manufacturing Engineer - Medical Device Validation (On-site PR)

EQVAL Group, Inc; Humacao (PR); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Life Insurance

Paid time off

Holidays

Professional Growth (EQVAL Academy)

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. is seeking a Manufacturing Engineer with strong experience in validation (IQ/OQ/PQ) and process optimization within Medical Device or Pharmaceutical environments.

The role focuses on executing validation, improving production efficiency, and ensuring regulatory compliance in a fast-paced setting. The ideal candidate will lead validation activities, design efficient manufacturing processes, troubleshoot issues, and collaborate across functions to support CAPA, NCRs, and

Qualifications

• Bachelor’s degree in Engineering required.
• Experience developing and executing validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ, and reports).
• Experience with FDA inspections, ISO audits, change control, non-conformance, and CAPA processes.
• Strong knowledge of cGMP for Medical Device manufacturing.
• Proficiency in statistical analysis and data management (GR&R, MSA) using tools like Minitab.

Responsibilities

• Lead and execute validation activities for equipment and process changes (IQ/OQ/PQ) and related documentation.
• Design and optimize manufacturing processes and layouts for efficient production.
• Troubleshoot equipment and processes to improve efficiency and product quality.
• Collaborate with cross-functional teams to support investigations and corrective actions.
• Ensure regulatory compliance (cGMP) across manufacturing and validation activities.

Skills

Validation execution

IQ/OQ/PQ

cGMP compliance

Lean manufacturing

Six Sigma

CAPA investigations

NCRs/Complaints handling

Familiar with FDA inspections

MSA/GR&R/DOE

Data analysis (Minitab)

Cross-functional collaboration

Bilingual English/Spanish

Education

Bachelor’s degree in Engineering

Tools

Minitab

DOE

GR&R

Job description

EQVAL Group, Inc. is seeking a Manufacturing Engineer with strong experience in validation (IQ/OQ/PQ) and process optimization within Medical Device or Pharmaceutical environments.

The role focuses on executing validation, improving production efficiency, and ensuring regulatory compliance in a fast-paced setting. The ideal candidate will lead validation activities, design efficient manufacturing processes, troubleshoot issues, and collaborate across functions to support CAPA, NCRs, and