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Commissioning Qualification Validation Cqv Jobs (NOW HIRING)

Wood Plc

It provides process engineering, process design, and commissioning - qualification - validation (CQV) services to pharmaceutical/biotechnology clients worldwide. For projects of every scale, we ...

Stark Pharma Solutions Inc

CQV Engineer

Austin, TX · On-site

Execute Commissioning, Qualification, and Validation (CQV) activities for manufacturing equipment, utilities, facilities, and process systems. * Develop, review, approve, and execute Installation ...

Centstone

Validation Engineer (CQV)

Lexington, KY · On-site

Lexington, KY Onsite Duration: Long term Positions: 3 Job Summary We are seeking a Validation Engineer to support Commissioning, Qualification, and Validation (CQV) activities for utilities, process ...

ValSource, Inc.

Experience Two (2) to five (5) or more years of Commissioning, Qualification and Validation (CQV ... experience in Pharmaceutical, Biotech, Medical Device or related GMP manufacturing environment ...

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How much do commissioning qualification validation cqv jobs pay per hour?

As of Jul 28, 2026, the average hourly pay for commissioning qualification validation cqv in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Commissioning Qualification Validation (CQV) professional, and why are they important?

To excel as a CQV professional, you need a solid background in engineering or life sciences, comprehensive knowledge of Good Manufacturing Practice (GMP), and experience with commissioning and validation processes. Familiarity with industry-standard software like ValGenesis, TrackWise, and documentation management systems, as well as certifications such as ISPE CQV or Six Sigma, is often required. Attention to detail, strong problem-solving abilities, and effective communication are crucial soft skills in this field. These competencies ensure equipment and processes meet regulatory standards, guarantee product quality, and support successful project delivery in highly regulated industries.

What are some typical challenges faced by Commissioning Qualification Validation (CQV) professionals during facility start-up projects?

CQV professionals often encounter challenges such as tight project timelines, evolving regulatory requirements, and coordination among cross-functional teams. During facility start-up, balancing documentation accuracy with rapid progress can be demanding, especially when unexpected technical issues arise. Additionally, aligning the expectations of engineering, quality assurance, and operations departments requires strong communication and adaptability. By proactively addressing these challenges, CQV professionals help ensure a smooth transition from construction to validated production.

What are Commissioning, Qualification, and Validation (CQV) professionals?

Commissioning, Qualification, and Validation (CQV) professionals are specialists who ensure that equipment, systems, and processes in industries like pharmaceuticals, biotechnology, and manufacturing meet regulatory standards and function as intended. They are responsible for planning, executing, and documenting activities that demonstrate compliance with quality and safety regulations. CQV experts play a critical role in bringing new facilities and systems into operation, guaranteeing that everything is tested and verified according to industry guidelines. Their work helps prevent failures, enhance product quality, and ensure patient or consumer safety.

What is the difference between Commissioning Qualification Validation Cqv vs Equipment Validation Specialist?

AspectCommissioning Qualification Validation CqvEquipment Validation Specialist
CredentialsGMP, FDA, or industry-specific certificationsGMP, FDA, or industry-specific certifications
Work EnvironmentPharmaceutical, biotech, or manufacturing facilities during project startupManufacturing or laboratory environments focusing on equipment performance
Employer & Industry UsageUsed in regulated industries for system and process validationUsed for validating individual equipment and systems

While both roles involve validation processes, Cqv focuses on the overall commissioning, qualification, and validation of systems and processes during facility startup. Equipment Validation Specialists primarily validate specific equipment performance. Both require similar certifications and work in regulated manufacturing environments, but their scope differs in focus and responsibilities.

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Commissioning Qualification Validation Cqv jobs near you
Infographic showing various Commissioning Qualification Validation Cqv job openings in the United States as of July 2026, with employment types broken down into 72% Full Time, and 28% Contract. Highlights an 96% In-person, and 4% Hybrid job distribution, with an average salary of $108,152 per year, or $52 per hour.

Director, Commissioning, Qualification & Validation (CQV)

RTD Biosciences

North Charleston, SC • On-site

Other

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

The Director of Commissioning, Qualification, and Validation (CQV) is responsible for leading the site-wide CQV program to ensure facilities, utilities, equipment, computerized systems, manufacturing processes, and laboratory systems are commissioned, qualified, and validated in compliance with current GMP regulations, FDA requirements, EU Annex 1, ICH guidelines, and company quality standards.

This position provides strategic leadership for CQV activities supporting clinical and commercial pharmaceutical manufacturing operations, including aseptic processing, lyophilization, packaging, laboratories, warehousing, and supporting utilities. The Director will build and maintain a sustainable validation lifecycle program while ensuring inspection readiness and operational excellence.


Essential Responsibilities

Strategic Leadership

  • Develop and execute the site CQV strategy supporting facility expansion, new product introduction, technology transfers, and commercial operations.
  • Establish site validation master plans (VMPs) and long-range CQV roadmaps.
  • Provide leadership and oversight for all commissioning, qualification, and validation activities.
  • Build and develop a high-performing CQV organization capable of supporting current and future manufacturing needs.
  • Serve as the site subject matter expert for validation and qualification requirements.

Facility, Utility, and Equipment Qualification

  • Oversee qualification of:
  • Cleanrooms and controlled environments
  • HVAC systems
  • Water systems (PW, WFI)
  • Clean steam systems
  • Compressed gases
  • Environmental monitoring systems
  • Manufacturing equipment
  • Packaging equipment
  • Laboratory instruments
  • Warehousing and cold storage systems
  • Ensure risk-based qualification approaches are implemented throughout the lifecycle.

Process Validation

  • Direct process validation activities in accordance with:
  • FDA Process Validation Guidance
  • ICH Q8, Q9, and Q10
  • EU GMP requirements
  • Approve validation protocols and reports.
  • Lead continued process verification (CPV) programs.
  • Support technology transfer and scale-up activities.

Computer System Validation (CSV/CSA)

  • Oversee qualification and validation of computerized systems including:
  • MES
  • LIMS
  • ERP systems
  • SCADA systems
  • Building management systems
  • Environmental monitoring software
  • Electronic batch records
  • Implement risk-based Computer Software Assurance (CSA) principles.

Project Support

  • Partner with Engineering, Manufacturing, Quality, Regulatory Affairs, and Supply Chain teams on capital projects.
  • Ensure CQV requirements are integrated into project planning and execution.
  • Participate in FAT, SAT, and equipment acceptance activities.
  • Support startup and operational readiness activities.

Compliance and Inspection Readiness

  • Ensure validation programs remain compliant with:
  • FDA cGMP requirements
  • EU GMP Annex 1
  • ICH guidance documents
  • USP standards
  • Data Integrity expectations
  • Represent the site during regulatory inspections and customer audits.
  • Address observations related to validation and qualification activities.

Quality Systems

  • Oversee validation-related:
  • Change Controls
  • Deviations
  • CAPAs
  • Risk Assessments
  • SOPs
  • Validation Master Plans
  • Ensure validation documentation is maintained in an audit-ready state.

Team Development

  • Recruit, train, mentor, and develop CQV professionals.
  • Establish performance objectives and succession planning.
  • Promote a culture of quality, compliance, accountability, and continuous improvement.


Qualifications

Education

  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or related scientific discipline required.
  • Master’s degree preferred.
  • Advanced technical certifications desirable.

Experience

  • Minimum 10–15 years of pharmaceutical, biotechnology, or sterile manufacturing experience.
  • Minimum 5–8 years of leadership experience managing validation or CQV teams.
  • Demonstrated experience supporting FDA, EMA, MHRA, and customer inspections.
  • Experience with facility startup, expansion, or greenfield projects strongly preferred.
  • Experience in aseptic processing and lyophilized product manufacturing preferred.

Apply