Quality EngineerSigma Systems, Inc. • Davie, Florida, United States
Quality Engineer
Sigma Systems, Inc. • Davie, Florida, United States
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[job_card.job_description]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. Assess and approve data flows, interfaces, and integrations between systems. Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems. 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. Any equivalent combination of education, training, or experience that fulfills the requirements of the position will be considered. Master's degree in Engineering, Computer Science, Life Sciences, or related field 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. 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 Werum Client-X, Seeq, PI Vision, Power BI (for regulated trending) Agile or lean validation approaches Commissioning & Qualification (C&Q) integration with CSV FDA inspections related to computerized systems Site digitalization or Industry 4.0 initiatives 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
9771 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
Data Integrity & Compliance :
Cross-Functional Collaboration
Position Requirements :
Education / Certification / Experience :
Strong working knowledge of :
Core Essential skill sets (must have) :
Preferred / Nice-to-Have :
Experience with :
Prior involvement in :
Key Competencies :
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Quality Engineer • Davie, Florida, United States
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