Utilization of the FAT, CQV, and Vertical Startup Processes with Suppliers and Operations teams, to ... NA ELT * Process Engineering Team * Operations Manager - New Products * Global Digital Team
Utilization of the FAT, CQV, and Vertical Startup Processes with Suppliers and Operations teams, to ... NA ELT * Process Engineering Team * Operations Manager - New Products * Global Digital Team
Utilization of the FAT, CQV, and Vertical Startup Processes with Suppliers and Operations teams, to ... NA ELT * Process Engineering Team * Operations Manager - New Products * Global Digital Team
Utilization of the FAT, CQV, and Vertical Startup Processes with Suppliers and Operations teams, to ... NA ELT * Process Engineering Team * Operations Manager - New Products * Global Digital Team
Cqv Engineer information
See Florida salary details
$24.7K - $32.1K
7% of jobs
$32.1K - $39.5K
2% of jobs
$39.5K - $46.9K
11% of jobs
$49.2K is the 25th percentile. Wages below this are outliers.
$46.9K - $54.3K
16% of jobs
$54.3K - $61.7K
14% of jobs
The median wage is $62K / yr.
$61.7K - $69.1K
14% of jobs
$69.1K - $76.5K
11% of jobs
$77.8K is the 75th percentile. Wages above this are outliers.
$76.5K - $83.9K
7% of jobs
$83.9K - $91.3K
12% of jobs
$91.3K - $98.7K
4% of jobs
$98.7K - $106.1K
3% of jobs
$24.7K
$66.6K
$106.1K
How much do cqv engineer jobs pay per year?
What does a CQV engineer do?
How much do CQV engineers make in the US?
What engineers make $300,000 a year?
What is a CQV Engineer job?
A CQV (Commissioning, Qualification, and Validation) Engineer is responsible for ensuring that equipment, systems, and processes within regulated industries, such as pharmaceuticals or biotechnology, meet regulatory and operational requirements. They develop and execute test protocols, troubleshoot issues, and document compliance with industry standards (e.g., FDA, GMP). Their role ensures that manufacturing facilities produce safe and effective products. CQV Engineers often collaborate with cross-functional teams, including quality, engineering, and operations.
What are some common challenges faced by CQV Engineers in the pharmaceutical industry?
CQV Engineers in the pharmaceutical industry often encounter challenges such as managing strict timelines while ensuring full compliance with regulatory standards and adapting to evolving project requirements. They must coordinate with multiple departments including QA, production, and engineering to align project goals and documentation. Additionally, troubleshooting unexpected technical issues and staying updated with the latest industry guidelines can be demanding. However, overcoming these challenges is rewarding, as it directly contributes to the safe and effective delivery of life-saving products.
What are the key skills and qualifications needed to thrive in the Cqv Engineer position, and why are they important?
To thrive as a CQV (Commissioning, Qualification, and Validation) Engineer, you need a solid background in engineering principles, GMP regulations, and life sciences or pharmaceutical processes, often supported by a relevant degree. Familiarity with quality management systems, risk assessment tools, and software for documentation and validation such as TrackWise or Veeva is commonly required, and certifications like Six Sigma or CQV-specific credentials are valuable. Strong analytical thinking, attention to detail, effective communication, and collaboration skills set top performers apart. These competencies are essential to ensure compliance, project success, and seamless interaction with cross-functional teams in highly regulated environments.
What engineer makes $500,000 a year?
- Verification And Validation
- Validation Associate
- Verification And Validation Engineer
- Computer System Validation Csv Remote
- Software Validation
- Validation Engineer Biomedical
- Computer System Validation Csv Pharmaceutical
- Medical Device Validation Engineer
- Validation Engineer Iq Oq Pq
- Vehicle Validation Engineer

Job description
Duration: 9 + months (possible extension)
Shift Schedule: Monday - Friday 8.00AM to 5.00PM
Temp to perm: Possible based on openings and performance
Core essential skill sets:
1. Minimum Master’s or PhD in Engineering (Chemical, Mechanical, Electrical, Industrial, Automation, or related) with 3+ years of experience
2. Hands-on CQV experience in a GMP Oral Solid Dose (OSD) facility supporting manufacturing and/or packaging operations.
3. Proven experience developing and executing IQ/OQ/PQ protocols and final reports in regulated environments.
4. Experience with Computerized System Validation (CSV), data integrity, and 21 CFR Part 11 compliance.
5. Strong understanding of OSD unit operations and equipment (e.g., blending, granulation, compression, coating, encapsulation and relevant automation including historian).
6. 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.
Screenings:
1. Basic Background
2.Drug -11-panel w/Fentanyl
3.Medical Screenings:
a) Vision Screen - Near, Far, Color, Depth and Peripheral
b) Audiogram & Noise and Hearing Questionnaire
c) Spirometry & OSHA Respirator Questionnaire
d) Lifting Assessment (35Lbs)
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.
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 cGMP, 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.
About Unicon Pharma
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
11 - 50 Employees
Headquarters location
Edison, NJ, US
Year founded
2013