Job Description
Job Description
9758 Quality Engineer, Davie, FL, 6 Months contract
Sigma. Inc is looking for a Quality Engineer to work onsite with our team located in Davie, FL
Shift: Monday – Friday 8.00 AM – 05:00 PM
Duration: 6 months with possibility to extend
Temp to Perm: Depending on opens and performance
Responsibilities:
- Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports).
- Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR Part 11, and Data Integrity (ALCOA+) principles.
- Evaluate system changes through change control, assessing GxP impact and validation requirements
- Support periodic reviews and re-validation activities for existing systems.
Digital Systems & Platforms
- Act as Quality reviewer/approver for systems including:
- MES / EBR platforms (e.g., Werum Client-X or similar)
- Historians (OSIsoft PI or equivalent)
- Advanced analytics tools (Seeq, used for GxP trending)
- Empower and other lab systems
- Review configurations related to data acquisition, time stamping, audit trails, access control, and electronic records/signatures.
- Ensure proper segregation between GxP vs non-GxP analytics use cases.
Data Integrity & Compliance:
- Assess and approve data flows, interfaces, and integrations between systems.
- Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems.
Cross-Functional Collaboration
- Partner with Engineering, Automation, MS&T, IT, and Operations to:
- Enable faster project execution with compliant validation strategies
- Avoid over-validation while maintaining inspection readiness
- Provide Quality input during project design, FAT/SAT, and commissioning phases.
Position Requirements:
- Any equivalent combination of education, training, or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
- Master's degree in Engineering, Computer Science, Life Sciences, or related field
Strong working knowledge of:
- CSV lifecycle & GAMP 5
- 21 CFR Part 11 / Annex 11
- Data Integrity (ALCOA+)
- Practical experience with:
- MES / EBR systems
- Process Historians (PI, etc.)
- Advanced analytics platforms (Seeq) in a GxP context
- Ability to evaluate risk-based validation for dashboards, reports, and models.
- Familiarity with change control, deviations, and CAPA systems.
Core Essential skill sets (must have):
- Recent Master's graduate Master's degree in Engineering, Computer Science, Life Sciences, or related field.
- Min 3 years experience in pharmaceutical or regulated manufacturing; out of which 2 years in quality organization
- Min 3 years hands-on CSV experience reviewing and approving validation documentation.
- Direct experience supporting manufacturing or utilities systems (not just lab systems).
- Medical screening requirements
Preferred / Nice-to-Have:
Experience with:
- Werum Client-X, Seeq, PI Vision, Power BI (for regulated trending)
- Agile or lean validation approaches
- Commissioning & Qualification (C&Q) integration with CSV
Prior involvement in:
- FDA inspections related to computerized systems
- Site digitalization or Industry 4.0 initiatives
Key Competencies:
- Risk-based decision making with quality and compliance focus
- Strong documentation review and technical writing skills
- Ability to challenge constructively while remaining solution-oriented
- Comfortable working at the intersection of Quality, Engineering, and IT
- Pragmatic mindset: compliant and business-enabling