Manufacturing Engineer: Validation & Process Optimization (Onsite PR)

EQVAL Group, Inc; Añasco (PR); Sur place; USD 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health insurance (Medical, Dental, Vis

Life Insurance

Paid time off

Holidays

EQVAL Academy courses

Referral program

Productivity incentive

Résumé du poste

EQVAL Group, Inc. in Puerto Rico is seeking a Manufacturing Engineer with medical device/pharma experience to lead validation activities (IQ, OQ, PQ) and optimize production processes.

The role focuses on troubleshooting, building robust validation documentation, supporting regulatory audits (FDA ISO), and driving continuous improvement with Lean and Six Sigma tools.

This on-site position in Juncos offers full-time work with benefits and opportunities for growth through EQVAL Academy.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience developing and executing validation documentation (Validation Plans, URS, FRS, IQ/OQ/PQ).
• Hands-on FDA inspections, ISO audits, change control, CAPA and non-conformance handling.
• Strong cGMP knowledge for medical device manufacturing.
• Proficiency in GR&R and data management using Minitab.
• Experience with NCRs/Complaints, Lean, Six Sigma, pFMEA, MSA, and DOE.
• Fully bilingual English/Spanish with strong communication skills.

Responsabilités

• Lead validation activities for equipment and process changes (IQ/OQ/PQ) and document results.
• Design and optimize manufacturing processes, layouts, and material handling.
• Troubleshoot equipment/process issues to improve efficiency and quality.
• Collaborate on investigations and implement corrective actions (NCRs, CAPA, complaints).
• Ensure regulatory compliance (cGMP) across manufacturing and validation activities.

Connaissances

GR&R

DOE

Six Sigma

Lean Manufacturing

MSA

Statistical analysis

Bilingual English/Spanish

Formation

Bachelor's degree in Engineering

Outils

Minitab

Description du poste

EQVAL Group, Inc. in Puerto Rico is seeking a Manufacturing Engineer with medical device/pharma experience to lead validation activities (IQ, OQ, PQ) and optimize production processes.

The role focuses on troubleshooting, building robust validation documentation, supporting regulatory audits (FDA ISO), and driving continuous improvement with Lean and Six Sigma tools.

This on-site position in Juncos offers full-time work with benefits and opportunities for growth through EQVAL Academy.