Quality Engineer – CSV & Digital Systems
Location: Davie, FL
Contract Duration: 6 months with possible extension
Shift Details: Monday to Friday 8am – 5 pm (40 hours per week)
Convert to Perm: Depending on opens and performance
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:
Screenings:
1. Basic Bkg
2. 11 Panel drug + Fentanyl
3. Medical Screenings:
a) Vision Screen - Near, Far, Color, Depth and Peripheral
b) Spirometry & OSHA Respirator Questionnaire
Key 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:
o MES / EBR platforms (e.g., Werum Client-X or similar)
o Historians (OSIsoft PI or equivalent)
o Advanced analytics tools (Seeq, used for GxP trending)
o 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:
o Enable faster project execution with compliant validation strategies
o Avoid over-validation while maintaining inspection readiness
• Provide Quality input during project design, FAT/SAT, and commissioning phases.
Required Qualifications:
Education:
• Master's degree in Engineering, Computer Science, Life Sciences, or related field.
Experience:
• 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).
Required Technical Skills
• Strong working knowledge of:
o CSV lifecycle & GAMP 5
o 21 CFR Part 11 / Annex 11
o Data Integrity (ALCOA+)
• Practical experience with:
o MES / EBR systems
o Process Historians (PI, etc.)
o 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 / Nice-to-Have
• Experience with:
o Werum Client-X, Seeq, PI Vision, Power BI (for regulated trending)
o Agile or lean validation approaches
o Commissioning & Qualification (C&Q) integration with CSV
• Prior involvement in:
o FDA inspections related to computerized systems
o 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.
Why Choose Cogent? Cogent Infotech stands at the forefront of technology consulting and is recognized globally for its award-winning services. With our headquarters in Pittsburgh, PA, USA, we specialize in guiding enterprises through digital transformation, leveraging the power of emerging technologies such as Cloud Computing, Cybersecurity, Data Analytics, and AI. Our mission is to provide innovative workforce solutions that address the complex challenges faced by today’s businesses.
As an ISO-certified firm and appraised at CMMI level 3, our reputation for excellence is well-established. We are proud to collaborate with over 70 Fortune 500 companies and more than 150 Federal C State agencies, delivering cutting-edge technology solutions that drive success.
Cogent is an equal opportunity employer. Cogent will not discriminate against applicants or employees based on race, color, religion, national origin, age, sex, pregnancy (including childbirth or related medical condition), genetic information, sexual orientation, gender
identity, military status, citizenship, or any other class protected by applicable law
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