Aequor · 2 days ago
Quality Engineer – CSV & Digital Systems
Davie, FL
Full-time
Hybrid
Mid Level
3+ years expAequor is a company specializing in quality engineering for pharmaceutical systems, and they are seeking a Quality Engineer focused on Computer System Validation and Digital Systems. The role involves reviewing and approving validation documentation, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to maintain quality and integrity across systems.
Cloud ComputingConsultingHuman ResourcesIT ManagementRecruiting
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 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
Qualification
Required
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)
Strong working knowledge of CSV lifecycle & GAMP 5
Strong working knowledge of 21 CFR Part 11 / Annex 11
Strong working knowledge of Data Integrity (ALCOA+)
Practical experience with MES / EBR systems
Practical experience with Process Historians (PI, etc.)
Practical experience with 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
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
Prior involvement in site digitalization or Industry 4.0 initiatives
Company
Aequor
Since 1998, Aequor has provided exceptional workforce staffing services in multiple industries.
201-500 employees
H1B Sponsorship
Aequor has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (1)
2022 (3)
2021 (1)
2020 (5)
Funding
Current Stage
Growth StageLeadership Team
Kamalpreet S. Virdi
CEO & Chairman
Recent News
Staffing Industry Analysts
2023-12-24
2023-07-11
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