Senior quality engineer h1.location_city

Quality Engineer - CSV / GxP Manufacturing

Davie, FL (Onsite)
Monday-Friday | 8:00 AM - 5:00 PM
6-Month Contract | Possible Extension / Temp-to-Perm
Sigma, Inc.

Sigma, Inc. is seeking a Quality Engineer to support computer system validation (CSV) and digital manufacturing systems at our onsite location in Davie, Florida. This role is ideal for a Quality professional with strong CSV, GxP, and manufacturing systems experience who thrives at the intersection of Quality, Engineering, and IT.

Key Responsibilities

Computer System Validation (CSV)

• Review, approve, and maintain CSV lifecycle documentation including:
  
  • VMP, URS, FRS, HDS
  • Risk Assessments, IQ/OQ/PQ
  • RTM and Validation Summary Reports
• Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ Data Integrity principles
• Evaluate system changes through change control, assessing GxP impact and validation requirements
• Support periodic reviews and re-validation of existing computerized systems

Digital Systems & Platforms

Act as Quality reviewer/approver for regulated systems including:

• MES / EBR platforms (Werum Client-X or similar)
• Process Historians (OSIsoft PI, PI Vision, or equivalent)
• Advanced analytics tools (Seeq for GxP trending)
• Empower and other laboratory systems

Review and approve system configurations related to:

• Data acquisition and interfaces
• Time stamping and audit trails
• User access controls
• Electronic records and electronic signatures
• Segregation of GxP vs non-GxP analytics use cases

Data Integrity & Compliance

• Assess and approve data flows, integrations, and interfaces
• Support FDA, EMA, and internal audits related to computerized systems
• Ensure continuous inspection readiness

Cross-Functional Collaboration

• Partner with Engineering, Automation, MS&T, IT, and Operations
• Provide Quality input during:
  
  • Project design
  • FAT / SAT
  • Commissioning and qualification phases
• Enable efficient project execution while avoiding over-validation

Required Qualifications

Education

• Master's degree in Engineering, Computer Science, Life Sciences, or related field
  (Recent graduates encouraged if experience requirements are met)

Experience

• Minimum 3 years in pharmaceutical or regulated manufacturing
• At least 2 years within a Quality organization
• 3+ years of hands-on CSV experience reviewing and approving validation documentation
• Direct experience supporting manufacturing or utilities systems (not lab-only)

Technical Knowledge

• CSV lifecycle & GAMP 5
• 21 CFR Part 11 / Annex 11
• Data Integrity (ALCOA+)
• Change control, deviations, and CAPA systems
• MES / EBR, Process Historians, and GxP analytics platforms

Preferred / Nice-to-Have

• Experience with:
  
  • Werum Client-X
  • Seeq
  • PI Vision
  • Power BI (regulated trending)
• Agile or Lean validation approaches
• C&Q integration with CSV
• Participation in FDA inspections
• Industry 4.0 or site digitalization initiatives

Key Competencies

• Risk-based decision making with strong compliance focus
• Excellent documentation review and technical writing skills
• Ability to challenge constructively and offer solutions
• Comfortable working across Quality, Engineering, and IT
• Pragmatic, business-enabling mindset