On-Site Validation Engineer: IQ/OQ/PQ & Process Optimization

EQVAL Group, Inc; Juncos (PR); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Life Insurance

Paid time off

Holidays

Professional Growth

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. is seeking Process Engineers with 3+ years in Medical Device or Pharmaceutical manufacturing to execute validation protocols (IQ, OQ, PQ) and optimize processes. The role requires collaboration across cross-functional teams, strong technical writing, and compliance with cGMP standards.

On-site position in Dorado, Puerto Rico. Ideal candidates will have a Bachelor's Degree in Engineering, experience with NCRs, CAPA, LEAN, and Six Sigma tools, and fluency in English and Spanish.

Qualifications

• Bachelor's degree in Engineering required.
• 3+ years of experience in Medical Device or Pharmaceutical industries.
• Experience developing and executing validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ).
• Experience with investigations (NCRs, Complaints, CAPA) and Lean/Six Sigma tools.
• Fully bilingual (English and Spanish) spoken and written.
• 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 protocols

Bilingual English/Spanish

Technical writing

Regulatory compliance

Education

Bachelor's degree in Engineering

Tools

Lean Manufacturing

Six Sigma

Job description

EQVAL Group, Inc. is seeking Process Engineers with 3+ years in Medical Device or Pharmaceutical manufacturing to execute validation protocols (IQ, OQ, PQ) and optimize processes. The role requires collaboration across cross-functional teams, strong technical writing, and compliance with cGMP standards.

On-site position in Dorado, Puerto Rico. Ideal candidates will have a Bachelor's Degree in Engineering, experience with NCRs, CAPA, LEAN, and Six Sigma tools, and fluency in English and Spanish.