Position Overview

As a Quality Engineer specializing in CSV, you will ensure computerized systems—including software and instruments—are compliant, validated, and reliable throughout their lifecycle, in line with FDA, GMP, ISO, and internal standards.

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Key Responsibilities

• Plan, execute, and document CSV activities (URS, IQ/OQ, PQ, validation reports) according to GAMP 5 and FDA guidance.

• Support CSV for LIMS, SCADA, MES, lab instruments, calibration systems, and other computerized tools.

• Maintain the QMS — update SOPs, validation templates, data integrity procedures, and risk assessments.

• Facilitate risk management efforts (e.g., FMEA), ensuring computerized systems are compliant and secure.

• Conduct internal audits of CSV processes—drive CAPA, deviations, and continuous improvement.

• Collaborate with IT, QA, manufacturing, lab operations, and external auditors to sustain validation readiness.

• Provide quality oversight for process validation, supplier systems, and qualification of new equipment or software.

• Prepare and present CSV documentation during customer or regulatory inspections.

These responsibilities incorporate classic Quality Engineer duties like equipment/process validation, quality issues, audits, and supplier quality—based on the Yauco QA Engineer role .

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Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.

• 3–5+ years of CSV experience in biotech, pharmaceutical, or medical device manufacturing.

• Strong working knowledge of GMP, FDA 21 CFR Part 11, GAMP 5, ISO 9001, and data integrity principles.

• Hands‑on experience writing validation protocols/reports (IQ, OQ, PQ) for lab/manufacturing systems.

• Familiarity with risk assessment tools (FMEA), change control, CAPA, and audit processes.

• Solid organizational skills and attention to detail.

• Excellent communication skills—effective in cross-functional and multi-site coordination.

• Preferred: ASQ Certification (CQE/CQA), Six Sigma/Lean, and experience with validation lifecycle tools and database systems.

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Desired Attributes

• Certification in GAMP 5 computer validation or related.

• Prior experience in cGMP lab environments, FDA inspections, or ISO‑audited facilities.

• Proficient with validation management systems (e.g., Veeva, MasterControl).

• Collaborative mindset and proactive problem solver.
   

**Weil Group is proud to be an Equal Employment Opportunity Employer.**