Manufacturing Engineer: Validation & Process Optimization

EQVAL Group, Inc; Ponce (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Life Insurance

Paid time off

Holidays

Growth opportunities

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. in Dorado, Puerto Rico, seeks Manufacturing Engineers with 3+ years in Medical Device or Pharmaceutical environments. The role centers on executing IQ/OQ/PQ validation, troubleshooting, and optimizing manufacturing processes on-site.

Ideal candidates hold a Bachelor’s in Engineering, have experience with validation docs and NCR/CAPA investigations, and are fluent in English and Spanish. Growth opportunities and competitive benefits are offered.

Qualifications

• Bachelor’s Degree in Engineering.
• Experience in validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ).
• Experience with NCRs, Complaints, CAPA, Lean Manufacturing, and Six Sigma tools.
• Experience with pFMEA and its application.
• Fully bilingual English and Spanish.
• Good technical writing skills.

Responsibilities

• Develop and execute validation activities for equipment and process changes (IQ, OQ, PQ) and associated documentation.
• Optimize manufacturing processes, ensuring efficient production layouts, material handling, and tool fabrication.
• 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 documentation

NCR/ CAPA investigations

Lean Manufacturing

Six Sigma tools

Bilingual English/Spanish

Technical writing

Education

Bachelor’s Degree in Engineering

Tools

pFMEA

Job description

EQVAL Group, Inc. in Dorado, Puerto Rico, seeks Manufacturing Engineers with 3+ years in Medical Device or Pharmaceutical environments. The role centers on executing IQ/OQ/PQ validation, troubleshooting, and optimizing manufacturing processes on-site.

Ideal candidates hold a Bachelor’s in Engineering, have experience with validation docs and NCR/CAPA investigations, and are fluent in English and Spanish. Growth opportunities and competitive benefits are offered.