CQV Lead

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Job ID:

10215172 Posted today Back Davie, FL, US Engineering Masters Degree Full Time, Temporary Master's degree: $45.00,

PhD:

$50.00 Experienced (Non-Manager) On-site Biotechnology/Pharmaceuticals First Shift (Day) Davie, FL, US Master's degree: $45.00,

PhD:

$50.00 Experienced (Non-Manager) Full Time, Temporary Biotechnology/Pharmaceuticals On-site Engineering Masters Degree First Shift (Day) Apply Now Applied Job details

Job Title:

CQV Lead Location :

Davie, FL. - Must be local. 100% onsite. There is no remote or hybrid option

Duration:

9 + months.

Temp to perm:

Possible based on openings and performance

Pay:

Pay rate for Master's degree: $45.00, Pay rate for

PhD:

$50.00

Shift:

Monday - Friday 8.00AM to 5.00PM .

Position Summary:

• Our client is seeking a CQV Lead with hands-on experience in Oral Solid Dose (OSD) manufacturing who brings both strong engineering fundamentals and a modern, digital-first approach to validation delivery.
• This role is intended for engineers who own qualification outcomes end-to-end—from interpreting design intent to defining critical parameters, executing risk-based protocols, and ensuring systems consistently perform within validated ranges.
• The CQV Lead will drive commissioning, qualification, and validation of manufacturing equipment, utilities, facilities, and computerized systems, ensuring compliance with cGMP, FDA, and data integrity expectations.
• Beyond execution, this role requires the ability to leverage digital tools and automation to improve the speed, quality, and traceability of validation deliverables—while maintaining full technical ownership of the final output.
• The candidate must be comfortable using automated/structured tools to generate draft documentation, and then independently reviewing, challenging, and approving content to ensure engineering accuracy, completeness, and regulatory defensibility.
• The ideal candidate holds a Master's or PhD in an Engineering discipline and demonstrates deep, hands-on CQV experience on the floor—understanding OSD unit operations, equipment design, integrated controls, and GMP documentation expectations.
• This role partners closely with QA, Automation, Engineering, and Manufacturing to deliver compliant, reliable, and inspection-ready systems. Key Responsibilities CQV Leadership & Execution
• Lead commissioning, qualification, and validation (CQV) activities for OSD manufacturing and packaging equipment, facilities, utilities, and computerized systems.
• Develop and execute risk-based

IQ/OQ/PQ

protocols aligned to critical quality attributes (CQAs) and critical process parameters (CPPs).

• Translate URS, FS/DS, and design intent into testable and traceable acceptance criteria.
• Evaluate system performance, operational ranges, and process reliability using sound engineering principles. Digital Validation & Documentation Ownership
• Utilize digital tools and structured templates to generate qualification documents efficiently (protocols, reports, traceability matrices).
• Perform rigorous manual technical review and approval of all generated content to ensure accuracy, completeness, and compliance.
• Ensure all executed evidence meets data integrity (ALCOA+) and GDP standards, and is inspection-ready. Lifecycle & Compliance Management
• Maintain validated state through lifecycle management, periodic reviews, and requalification decisions.
• Lead or support change control, deviation investigations, and CAPA implementation.
• Ensure alignment with c

GMP, FDA

regulations, and 21 CFR Part 11 expectations for computerized systems. Technical Problem Solving

• Identify and challenge critical parameters, control strategies, and system design assumptions.
• Troubleshoot equipment, utilities, and automation interfaces (PLC/SCADA/historian integrations) impacting qualification outcomes. Cross-Functional Delivery
• Partner with QA, MS&T, Automation, and Manufacturing teams to ensure successful project execution and inspection readiness.
• Provide clear communication of risks, timelines, and technical decisions. Minimum Requirements
• Master's or PhD in Engineering (Chemical, Mechanical, Electrical, Industrial, Automation, or related) with 3+ years of experience
• Hands-on CQV experience in a GMP Oral Solid Dose (OSD) facility supporting manufacturing and/or packaging operations.
• Proven experience developing and executing

IQ/OQ/PQ

protocols and final reports in regulated environments.

• Experience with Computerized System Validation (CSV), data integrity, and 21 CFR Part 11 compliance. Technical & Functional Competencies
• Strong understanding of OSD unit operations and equipment (e.g., blending, granulation, compression, coating, encapsulation and relevant automation including historian).
• Ability to interpret mechanical, electrical, and control system designs and identify critical parameters.
• Familiarity with automation systems (PLC/SCADA) and data historians (e.g., PI).
• Excellent technical writing skills with a focus on inspection-ready documentation.
• Ability to analyze complex systems, assess risk, and drive data-based decisions.

Core essential skill sets:

• Minimum Master's or PhD in Engineering (Chemical, Mechanical, Electrical, Industrial, Automation, or related) with 3+ years of experience
• Hands-on CQV experience in a GMP Oral Solid Dose (OSD) facility supporting manufacturing and/or packaging operations.
• Proven experience developing and executing

IQ/OQ/PQ

protocols and final reports in regulated environments.

• Experience with Computerized System Validation (CSV), data integrity, and 21 CFR Part 11 compliance.
• Strong understanding of OSD unit operations and equipment (e.g., blending, granulation, compression, coating, encapsulation and relevant automation including historian).
• Ability to interpret mechanical, electrical, and control system designs and identify critical parameters.
• Familiarity with automation systems (PLC/SCADA) and data historians (e.g., PI).
• Excellent technical writing skills with a focus on inspection-ready documentation.
• Ability to analyze complex systems, assess risk, and drive data-based decisions.

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

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