Quality Engineer – CSV & Digital Systems Job Listing at Kelly Services in Davie, FL (Job ID 10136389)

Description

Job Title: Quality Engineer – CSV & Digital Systems
Location: Davie, FL – ONSITE. Local candidates Only
Duration: 6 months with Possible Extensions. Possibility of temp to perm
Pay: $41.61/hr.
Shift: Monday to Friday 8am – 5 pm (40 hours per week)

Required skill sets (must have):
• Recent Master's graduate Master's degree in Engineering, Computer Science, Life Sciences, or related field.
• Min 3 years of 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).

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 PAS-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 PAS-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 Kelly?
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

• Exposure to a variety of career opportunities as a result of our expansive network of client companies 
• Career guides, information and tools to help you successfully position yourself throughout every stage of your career
• Access to more than 3,000 online training courses through our Kelly Learning Center
• Weekly pay and service bonus plans
• Group-rate insurance options available immediately upon hire*

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Technology?

Looking to put your tech expertise to work on today's most intriguing, innovative, and high-visibility projects? By partnering with Kelly Technology, you'll gain direct connections to top companies around the globe. Our team creates expert talent solutions to solve the world's most critical challenges. In a world where change is the only constant, our extensive network of industry relationships and IT market expertise help you take your skills exactly where you want to go. We're here to help you gain experience, make an impact, and grow your tech career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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