Validation Process Engineer – Med Devices & Pharma

EQVAL; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Life Insurance

Paid time off (PTO)

Holidays

EQVAL Academy courses

Job summary

EQVAL Group, Inc. is seeking Process Engineers with at least three years of experience in Medical Device or Pharmaceutical industries. The role focuses on executing validation protocols (IQ, OQ, PQ), troubleshooting, and optimizing manufacturing processes. On-site, Dorado, Puerto Rico.

The position requires a Bachelor's degree in Engineering and experience with validation documents, NCRs/Complaints, CAPA, Lean, and Six Sigma tools. Bilingual in English and Spanish is essential.

Qualifications

• Bachelor's degree in Engineering required.
• Experience with validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ).
• Experience with NCRs, Complaints, CAPA, Lean Manufacturing, and Six Sigma tools.
• Familiarity with pFMEA and its application.
• Fully bilingual in English and Spanish, spoken and written.

Responsibilities

• Develop and execute validation activities for equipment and process changes (IQ, OQ, PQ) and associated documentation.
• Optimize manufacturing processes and layouts for efficient production and material handling.
• Troubleshoot and improve production equipment and processes to enhance quality and efficiency.
• Collaborate with cross-functional teams to support investigations and implement corrective actions (NCRs, Complaints, CAPA).
• Ensure regulatory compliance with cGMP across manufacturing and validation activities.

Skills

Bilingual English/Spanish

Technical writing

NCRs/Complaints investigations

Process improvement

Problem solving

Education

Bachelor's degree in Engineering

Tools

pFMEA

LEAN Manufacturing

Six Sigma tools

Validation Plans/IQ/OQ/PQ

Job description

EQVAL Group, Inc. is seeking Process Engineers with at least three years of experience in Medical Device or Pharmaceutical industries. The role focuses on executing validation protocols (IQ, OQ, PQ), troubleshooting, and optimizing manufacturing processes. On-site, Dorado, Puerto Rico.

The position requires a Bachelor's degree in Engineering and experience with validation documents, NCRs/Complaints, CAPA, Lean, and Six Sigma tools. Bilingual in English and Spanish is essential.