Position Overview

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

Key Responsibilities

Plan, execute, and document validation 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 systems are compliant and secure.
Conduct internal audits of system validation 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 validation 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 .

Required Qualifications

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
3–5+ years of validation 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.

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.**