Manufacturing Engineer

About the role

EQVAL Group, Inc. is seeking a Manufacturing Engineer with experience in the Medical Device or Pharmaceutical sectors. The role focuses on executing equipment and process validation (IQ, OQ, PQ), optimizing manufacturing workflows, and ensuring compliance with cGMP and regulatory standards in a fast‑paced environment.

Key responsibilities

• Lead and document validation activities for equipment and process changes, including IQ, OQ, PQ, Validation Plans, URS, and FRS.
• Design and improve manufacturing processes, layouts, material handling, and tooling.
• Troubleshoot production equipment and processes to boost efficiency and product quality.
• Collaborate with cross‑functional teams on investigations (NCRs, complaints) and implement corrective actions.
• Maintain compliance with cGMP, FDA inspections, ISO certifications, change control, and CAPA procedures.

Required profile

• Bachelor’s degree in an Engineering discipline.
• Proven experience developing and executing validation documentation.
• Hands‑on experience with FDA inspections, ISO audits, and regulatory compliance.
• Fully bilingual in English and Spanish with strong written and verbal communication.

Required skills

• Validation (IQ, OQ, PQ) and related documentation (Validation Plans, URS, FRS).
• cGMP knowledge for Medical Device manufacturing.
• Statistical analysis (GR&R) and data management tools such as Minitab.
• Lean Manufacturing and Six Sigma methodologies.
• pFMEA analysis and development.
• Measurement System Analysis (MSA), Attribute Analysis, and Design of Experiments (DOE).

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.