Manufacturing Equipment Validation Lead (IQ/OQ)

Pinnaql, Inc.; Aguadilla (PR); Presencial; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

Validation & Engineering Group, Inc. is seeking a Manufacturing Equipment Specialist to lead qualification of lab equipment and production systems at client sites in the pharmaceutical and biotech sectors.

You will verify equipment, prepare IQ/OQ protocols, maintain documentation, and coordinate with vendors and internal teams to ensure compliant qualification packages. Strong knowledge of GMP, GDP, and data integrity is required; English communication essential; Spanish preferred for site

Formación

• Bachelor's degree in Engineering or related field.
• Experience developing and executing qualification protocols or CSV lifecycle documents and tests.
• Experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments.
• Working knowledge of GMP regulations, GDP, regulatory guidance, data integrity principles, risk-based qualification and validation, and FDA cGMP requirements and ISPE/GAMP principles.
• Ability to interpret User Requirements Specifications, design documents, drawings, functional specifications, control narratives, vendor documentation, calibration records, and commissioning evidence.
• Demonstrated ability to write clear qualification or validation documents and reports and to execute testing accurately.

Responsabilidades

• Review the applicable User Requirements Specification, design documents, drawings, vendor manuals, commissioning records, calibration records, certificates, risk assessments, and other lifecycle documents.
• Confirm qualification boundary, components, prerequisites, test strategy, acceptance criteria, and needed documentation for protocol development and execution.
• Perform field walkdowns and document reviews to confirm readiness for qualification.
• Generate IQ/OQ protocol using current Company procedures and templates.
• Incorporate comments and support protocol routing until approval for execution.
• Execute approved IQ/OQ protocol in accordance with company procedures and GDP.

Educación

Bachelor's degree in Engineering or related field

Descripción del empleo

Validation & Engineering Group, Inc. is seeking a Manufacturing Equipment Specialist to lead qualification of lab equipment and production systems at client sites in the pharmaceutical and biotech sectors.

You will verify equipment, prepare IQ/OQ protocols, maintain documentation, and coordinate with vendors and internal teams to ensure compliant qualification packages. Strong knowledge of GMP, GDP, and data integrity is required; English communication essential; Spanish preferred for site