Quality Engineer - Davie - Aequor Technologies

    Aequor Technologies
    Aequor Technologies Davie

    5 days ago

    Description

    Title:
    Quality Engineer - CSV & Digital Systems

    Pay Rate:
    ***Bill Rate: ***Shift Details: Monday to Friday 8am - 5 pm (40 hours per week)
    Assignment Duration: 6 months with possible extension

    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:

    • Basic Bkg
    2. 11 Panel drug + Fentanyl

    • 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
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