Quality Engineer – CSV & Digital Systems

SGS_JOB_3475

Engineering
 Florida
Computer System Validation (CSV)
GAMP 5
21 CFR Part 11
Data Integrity (ALCOA+)
MES/EBR
OSIsoft PI
Seeq
Empower
Validation Documentation
Risk-Based Validation
Pharmaceutical Manufacturing
Utilities Systems

Contract - 6 months Contract (with possible extension; convert to perm depending on openings and performance)

Location: Davie, FL, 33314 Small Description: Seeking a Quality Engineer with expertise in CSV and digital systems to support manufacturing and utilities systems in a regulated pharmaceutical environment. The role involves reviewing and approving validation documentation, ensuring compliance with GxP, FDA, and EMA regulations, and supporting cross-functional teams in digitalization initiatives.

Job 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.
  • Act as Quality reviewer/approver for MES / EBR platforms (e.g., Werum PAS-X or similar), Historians (OSIsoft PI), Advanced analytics tools (Seeq), 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, and maintain inspection readiness.
  • Provide Quality input during project design, FAT/SAT, and commissioning phases.  

Skills:

  • 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), 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.
  • Preferred: Werum PAS-X, Seeq, PI Vision, Power BI, Agile/Lean validation approaches, C&Q integration with CSV.
  • Experience with FDA inspections related to computerized systems and site digitalization or Industry 4.0 initiatives.
  • Key competencies: Risk-based decision making, strong documentation review and technical writing skills, ability to challenge constructively, pragmatic mindset, and comfortable working at the intersection of Quality, Engineering, and IT.

Education/Experience:

  • Recent Master’s graduate in Engineering, Computer Science, Life Sciences, or related field.
  • 3–5 years experience in pharmaceutical or regulated manufacturing; minimum 2 years in quality organization.
  • 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: Basic background check, 11-panel drug + Fentanyl, Vision screen (Near, Far, Color, Depth, Peripheral), Spirometry & OSHA Respirator Questionnaire.

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