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Cqv Engineer Jobs in Raleigh, NC (NOW HIRING)

Stellent IT LLC

CQV Lead, Upstream

Holly Springs, NC · On-site

$88K - $116K/yr

Title - CQV Lead, Upstream Location: Holly Springs, North Carolina Visa - OPEN NEED LEAD CANDIDATE ONLY WITH LINKEDIN PROFILE seeking a highly experienced CQV (Commissioning, Qualification, and ...

CAI

Senior Validation Engineer

Raleigh, NC · On-site

$87K - $120K/yr

Key Responsibilities CQV Execution & Safety - Perform Commissioning, Qualification, and Validation ... (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for ...

Fujifilm

Senior QA Engineer, Validation

Holly Springs, NC · On-site

$76K - $103K/yr

Position Overview The Senior QA Engineer, Validation helps drive the Quality oversight for ... Serves as QA CQV subject matter expert (SME) with regulators, clients, and company management.

CAI

Senior Validation Engineer

Raleigh, NC · On-site

$87K - $120K/yr

Key Responsibilities CQV Execution & Safety - Perform Commissioning, Qualification, and Validation ... (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for ...

247Hire

Process Engineer

Raleigh, NC · On-site

$150/hr

CQV & MC10. Will this roleauthor, review, or executeIQ/OQ protocols, or primarily provide technical support to CQV? 11. Do you follow arisk-based/AES/A2500-styleCQV model that the candidate should be ...

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Showing results 21-40

All JobsCqv Engineer JobsCqv Engineer Jobs in Raleigh, NC

Cqv Engineer information

See Raleigh, NC salary details

$32.1K

$86.7K

$138K

How much do cqv engineer jobs pay per year?

As of Sep 13, 2026, the average yearly pay for cqv engineer in Raleigh, NC is $86,693.00, according to ZipRecruiter salary data. Most workers in this role earn between $64,600.00 and $106,000.00 per year, depending on experience, location, and employer.

What is a CQV engineer?

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 the key skills and qualifications needed to thrive as a CQV engineer?

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 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.

How much do CQV engineers make in the US?

CQV (Commissioning, Qualification, and Validation) engineers in the US typically earn between $80,000 and $130,000 annually, depending on experience, location, and industry. Senior or specialized engineers with certifications and extensive expertise can earn higher salaries, often exceeding $150,000. The role often requires knowledge of regulatory standards and validation tools.

What are popular job titles related to Cqv Engineer jobs in Raleigh, NC?

For Cqv Engineer jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Cqv Engineer jobs in Raleigh, NC look for?

The top searched job categories for Cqv Engineer jobs in Raleigh, NC are:

Cqv Engineer jobs near you
Infographic showing various Cqv Engineer job openings in Raleigh, NC as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $86,693 per year, or $41.7 per hour.

Project Manager - Senior CQV Pharmaceutical

Raleigh, NC • On-site

Visium Resources, Inc.
Recruiting and Staffing Services • 51 - 200 employees
Learn more about Visium Resources, Inc.external

Contractor

Re-posted 28 days ago

Job description

Introduction
Visium Resources has been asked to identify qualified candidates for a full time position as a Senior CQV Project Manager located in Raleigh, NC. We are seeking an experienced Senior CQV Project Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives. This individual will oversee cross-functional CQV execution for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes while ensuring compliance with FDA, cGMP, and global regulatory standards.


The ideal candidate will possess strong pharmaceutical project leadership experience within biotech, sterile manufacturing, fill-finish, API, or biologics environments and will serve as a key liaison between engineering, quality, validation, manufacturing, and external vendors. This role requires the ability to manage project schedules, budgets, risks, resources, and validation deliverables in support of facility expansions, new product introductions, and operational readiness initiatives.


Key Success Criteria
  • Experience leading major expansion C&Q projects start to finish (brownfield or greenfield). From strategy / planning through to full doc prep & execution
  • Writes CQV Strategies & Plans.
  • CQV Schedule
  • Should have experience with C&Q of process equipment.
  • Has experienced with integrated CQV (ASTM E2500 and ISPE C&Q baseline guide)
  • Has experience with digital validation (i.e. Kneat or other software) is a major asset but not required.
  • Capital Improvements experience is a major asset but not required.

Key Responsibilities
  • Lead all CQV project activities for pharmaceutical and biotech manufacturing projects. 
  • Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation. 
  • Coordinate commissioning and qualification activities for: 
    • Process equipment 
    • Clean utilities 
    • HVAC systems 
    • Automation and control systems 
    • Manufacturing and packaging lines 
  • Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. 
  • Oversee execution of: 
    • FAT/SAT protocols 
    • IQ/OQ/PQ protocols 
    • Validation documentation 
    • Deviations and CAPAs 
    • Change controls 
  • Collaborate with Quality Assurance, Engineering, Manufacturing, Automation, and Regulatory teams to support project milestones and inspection readiness. 
  • Manage third-party CQV consultants, contractors, and vendors. 
  • Provide risk assessments and mitigation strategies to maintain project timelines and compliance objectives. 
  • Support startup, operational readiness, and technology transfer activities. 
  • Present project status updates and KPI reporting to senior leadership and stakeholders.

Qualified candidates would have the following:

  • Minimum 8-12 years of experience in pharmaceutical, biotech, or life sciences industries. 
  • Minimum 5 years of direct CQV project management experience within GMP-regulated manufacturing environments. 
  • Proven experience managing large-scale capital projects, facility expansions, or greenfield startup projects. 
  • Strong experience with commissioning and qualification of: 
    • Cleanrooms 
    • Process equipment 
    • Utilities 
    • Automation systems 
    • Manufacturing processes 
  • Experience authoring and reviewing validation lifecycle documentation. 
  • Demonstrated success leading cross-functional teams and managing multiple project workstreams simultaneously. 
  • Experience supporting FDA audits and regulatory inspections. 
  • Background in biologics, sterile fill-finish, vaccine, API, or aseptic manufacturing environments strongly preferred. 

Required Qualifications
  • Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline. 
  • Strong understanding of: 
    • cGMP regulations 
    • FDA validation requirements 
    • ISPE Baseline Guides (inc. C&Q) and ASTM E2500 GUIDE
    • GAMP 5 principles 
  • Proficiency with project management methodologies, scheduling tools, and reporting systems. 
  • Excellent communication, leadership, and stakeholder management skills. 
  • Ability to work effectively in fast-paced, highly regulated project environments. 

Preferred Qualifications
  • Digital Validation software experience (i.e. Kneat or equivalent)
  • PMP certification preferred. 
  • Experience with DeltaV, MES, SCADA, or other pharmaceutical automation platforms. 
  • Familiarity with Kneat, TrackWise, Veeva, or electronic validation systems. 
  • Previous consulting or EPCM experience is a plus. 
  • Lean Six Sigma certification preferred.

________________________________________________________________________________________________


Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company's success is based on your success. When you work with us, you are never 'just a number'. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium.
Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.

Education:BS/BA DegreeEmployment Type: CONTRACTOR

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