Manufacturing Engineer – Validation & Process Optimization

About the role

We are looking for a Manufacturing Engineer to lead validation activities and optimize manufacturing processes for medical device and pharmaceutical production. The role will be based on‑site in Dorado, Puerto Rico, working closely with cross‑functional teams to ensure compliance and efficiency.

Key responsibilities

• Develop and execute equipment and process validation protocols (IQ, OQ, PQ) and produce associated documentation.
• Optimize production layouts, material handling, and tool fabrication to improve efficiency.
• Troubleshoot and enhance production equipment and processes to boost operational performance and product quality.
• Support investigations (NCRs, complaints) and implement corrective actions in collaboration with other departments.
• Maintain compliance with cGMP and other regulatory standards throughout all activities.

Required profile

• Bachelor’s degree in Engineering.
• Minimum three years of experience in the medical device or pharmaceutical industry.
• Proven experience creating validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ).
• Experience handling investigations, CAPA, and applying Lean and Six Sigma tools.
• Hands‑on experience with pFMEA analysis and implementation.
• Fluent in English and Spanish, both written and spoken.
• Strong technical writing abilities.

Required skills

• IQ/OQ/PQ validation protocols
• pFMEA analysis
• Lean Manufacturing
• Six Sigma methodology
• cGMP compliance

What we offer

• Comprehensive health insurance (medical, dental, vision, pharmacy)
• Life insurance
• Paid time off and holidays
• Professional development through EQVAL Academy courses and certifications
• Referral program and productivity incentives
• Competitive compensation