Quality Engineer (CSV)
Quality Engineer (CSV)
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Job Description
Position Overview
As a Quality Engineer specializing in CSV you will ensure computerized systemsincluding software and instrumentsare compliant validated and reliable throughout their lifecycle in line with FDA GMP ISO and internal standards.
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 processesdrive 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 qualitybased on the Yauco QA Engineer role .
Required Qualifications
Bachelors degree in Engineering Computer Science Life Sciences or related field.
35 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.
Handson 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 skillseffective 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 ISOaudited 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.**
Employment Type
Full Time
