Manufacturing Validation Engineer – Medical Devices

EQVAL Group, Inc; Ponce (PR); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Life Insurance

PTO

Holidays

Professional Growth (EQVAL Academy)

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. in Puerto Rico is seeking a Manufacturing Engineer to drive process validation and optimize manufacturing workflows for Medical Device and Pharmaceutical projects. The role focuses on IQ, OQ, PQ, and continuous improvement in a regulated environment.

You will collaborate with cross-functional teams, support investigations, prepare validation documentation, and ensure cGMP and ISO compliance. Fluency in English and Spanish is required; this is a full-time, on-site position.

Qualifications

• Bachelor’s degree in Engineering or related field required.
• Experience in Medical Device or Pharmaceutical industries with validated processes.
• Experience developing and executing validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ).
• Familiarity with regulatory standards (cGMP, FDA inspections, ISO audits, CAPA).

Responsibilities

• Execute validation activities for equipment and process changes, including IQ, OQ, PQ, and associated documentation.
• Design and optimize manufacturing processes, ensuring efficient production layouts and material handling.
• Troubleshoot and improve production equipment and processes to enhance operational efficiency and product quality.
• Collaborate with cross-functional teams to support investigations (NCRs, Complaints) and implement corrective actions.
• Ensure compliance with regulatory standards (cGMP) in all manufacturing processes and validation activities.

Skills

Validation experience (IQ/OQ/PQ)

Troubleshooting

Lean Manufacturing

Six Sigma

NCRs/Complaints/CAPA investigations

Bilingual English/Spanish

Communication skills

Education

Bachelor’s degree in Engineering

Tools

Minitab

Job description

EQVAL Group, Inc. in Puerto Rico is seeking a Manufacturing Engineer to drive process validation and optimize manufacturing workflows for Medical Device and Pharmaceutical projects. The role focuses on IQ, OQ, PQ, and continuous improvement in a regulated environment.

You will collaborate with cross-functional teams, support investigations, prepare validation documentation, and ensure cGMP and ISO compliance. Fluency in English and Spanish is required; this is a full-time, on-site position.