Validation Engineer / Specialist

About the role

The Validation Engineer / Specialist will support validation and qualification activities within a medical‑device and pharmaceutical manufacturing environment. The role involves creating, executing, and documenting validation protocols to ensure compliance with industry standards.

Key responsibilities

• Develop and maintain validation documentation including Validation Assessments, Validation Plans, URS, FRS, IQ, OQ, and PQ reports.
• Execute validation protocols and generate comprehensive reports.
• Design and implement Measurement System Analysis (MSA) studies such as Attribute Analysis, GR&R, and Design of Experiments.
• Utilize Minitab for statistical analysis and data interpretation.
• Collaborate with cross‑functional teams to ensure validation activities meet customer and regulatory requirements.

Required profile

• Bachelor’s degree in an engineering discipline.
• Proven experience in validation/qualification within medical‑device or pharmaceutical manufacturing.
• Fluent in English and Spanish with strong written communication skills.

Required skills

• Validation documentation (IQ, OQ, PQ, URS, FRS).
• Measurement System Analysis, Attribute Analysis, GR&R, DOEs.
• Statistical analysis using Minitab.

What we offer

• Health, dental, vision and pharmacy insurance.
• Life insurance and paid time off.
• Professional development through EQVAL Academy courses and certifications.
• Referral program and productivity incentives.