Validation Engineer

About the role

EQVAL Group, Inc. is seeking a Validation Engineer to join its team in Dorado, Puerto Rico. The role focuses on executing validation protocols, troubleshooting, and optimizing manufacturing processes for medical device and pharmaceutical production.

Key responsibilities

• Develop and execute validation activities for equipment and process changes, including IQ, OQ, and PQ, and produce associated documentation.
• Optimize manufacturing processes, ensuring efficient layouts, material handling, and tool fabrication.
• Troubleshoot production equipment and processes to improve operational efficiency and product quality.
• Collaborate with cross‑functional teams to support investigations (NCRs, complaints) and implement corrective actions.
• Maintain compliance with cGMP and other regulatory standards throughout all validation activities.

Required profile

• Bachelor’s degree in Engineering.
• Minimum three years of experience in the medical device or pharmaceutical industry.
• Fully bilingual in English and Spanish, both spoken and written.
• Strong technical writing abilities.

Required skills

• Experience creating and executing validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ).
• Proficiency with investigations (NCRs, complaints, CAPA), Lean Manufacturing, and Six Sigma tools.
• Knowledge of pFMEA analysis and application.
• Understanding of cGMP regulatory requirements.

What we offer

• Health insurance (medical, dental, vision, pharmacy).
• Life insurance and paid time off.
• Professional growth through courses and certifications via EQVAL Academy.
• Referral program and productivity incentives.