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Quality Engineer – CSV & Digital Systems

Iconma

Davie, FL

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JOB DETAILS
SKILLS
Access Control, Agile Programming Methodologies, Automation, Biology, Biotech and Pharmaceutical, Change Control, Code of Federal Regulations, Commissioning, Computer Science, Computer Systems, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Data Quality, Documentation Review, Drug Manufacturing, FDA (Food and Drug Administration), FDA Requirements, Genetics, GxP, Health Plan, Information Technology & Information Systems, Internal Audit, Laboratory Systems, Manufacturing Execution Systems (MES), Manufacturing Systems, Power BI, Process Validation, Project Design, Project Execution, Quality Engineering, Reporting Dashboards, Requirements Validation/Verification, Risk, Risk Analysis, System Validation, Technical Writing, Use Cases, Validation Documentation, Writing Skills
LOCATION
Davie, FL
POSTED
1 day ago
Our Client, a Pharmaceutical company, is looking for a Quality Engineer – CSV & Digital Systems for their Davie, FL location.
 
Responsibilities:
Computer System Validation (CSV)
  • 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 PAS-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.
 
Requirements:
  • Master's degree in Engineering, Computer Science, Life Sciences, or related field.
  • 3-5 years experience in pharmaceutical or regulated manufacturing; out of which 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).
  • CSV lifecycle & GAMP 5
  • 21 CFR Part 11 / Annex 11
  • Data Integrity (ALCOA+)
  • 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.
  • Werum PAS-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
 
Why Should You Apply?
  • Health Benefits
  • Referral Program
  • Excellent growth and advancement opportunities
 
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.

About the Company

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/