Senior Validation Engineer -- GOEDC5799328

Senior Validation Engineer -- GOEDC5799328 at Compunnel Inc. Senior Validation Engineer -- GOEDC5799328 at Compunnel Inc. in Dania, Florida Posted in about 20 hours ago.

Type:

full-time

Job Description:

Position Summary:

We are 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.

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.

Compunnel Inc. is an Equal Employment Opportunity (EEO) employer committed to fostering an inclusive, diverse, and equitable workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, citizenship status, age, disability, protected veteran status, marital status, genetic information, or any other characteristic protected by applicable federal, state, or local law. As a global workforce solutions provider, Compunnel values diversity of thought, background, and experience, and believes an inclusive workforce strengthens innovation and client success.