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Fda Jobs in Raleigh, NC (NOW HIRING)

Visium Resources, Inc.

Pharmaceutical Engineer

Raleigh, NC · On-site

$120K - $145K/yr

This role requires hands-on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The Senior CQV Engineer will work cross ...

Stark Pharma Solutions Inc

CAPA Specialist

Durham, NC · On-site

Develop, revise, and improve Risk Management procedures in compliance with FDA and ISO 13485 requirements. * Review and remediate existing quality records using risk-based decision-making. * Plan ...

MedPharm

Cleaning Validation Engineer

Durham, NC · On-site

Develop and maintain the Cleaning Validation Master Plan (CVMP) in alignment with FDA, ICH Q9, ASTM E2500, and EU Annex 1 * Establish lifecycle validation strategies (Stages 1-3, including CPV)

JobRx, Inc.

Director, Regulatory Affairs

Durham, NC · On-site

$130 - $160/hr

Serves as the primary contact for all interactions with regulatory agencies such as the FDA. Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory ...

MedPharm

Cleaning Validation Engineer

Durham, NC · On-site

Develop and maintain the Cleaning Validation Master Plan (CVMP) in alignment with FDA, ICH Q9, ASTM E2500, and EU Annex 1 * Establish lifecycle validation strategies (Stages 1-3, including CPV)

Kelly Services

QA Systems Specialist

Raleigh, NC

$76K - $110K/yr

Ensure compliance with cGMP, FDA, and applicable regulatory requirements. * Review quality documentation, including change controls, deviations, investigations, risk assessments, and related quality ...

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Fda information

See Raleigh, NC salary details

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How much do fda jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for fda in Raleigh, NC is $38.03, according to ZipRecruiter salary data. Most workers in this role earn between $23.70 and $47.40 per hour, depending on experience, location, and employer.

What does an FDA professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood safety, product development, research

While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

What qualifications do you need to work for the Food and Drug Administration?

To work for the Food and Drug Administration (FDA), candidates typically need a bachelor's degree in a relevant field such as science, engineering, or healthcare. Many positions require specialized knowledge, experience, or advanced degrees, and some roles may require professional certifications or licenses. Strong analytical skills, attention to detail, and familiarity with regulatory guidelines are also important.

What are the most commonly searched types of Fda jobs in Raleigh, NC?

The most popular types of Fda jobs in Raleigh, NC are:

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

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

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

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

What cities near Raleigh, NC are hiring for Fda jobs?

Cities near Raleigh, NC with the most Fda job openings:

Fda jobs near you
Infographic showing various Fda job openings in Raleigh, NC as of August 2026, with employment types broken down into 79% Full Time, and 21% Contract. Highlights an 100% In-person job distribution, with an average salary of $79,108 per year, or $38 per hour.

Senior Pharmaceutical CQV Engineer

Visium Resources, Inc.

Raleigh, NC

Full-time

Re-posted 4 days ago

Job description

Introduction
Visium Resources has been asked to identify qualified candidates for this Pharmaceutical Senior CQV Engineer position. This position is a direct hire which is expected to be on-site in Raleigh, NC. Candidates must be a US Citizen or US Permanent Resident.


Summary

We are seeking a highly motivated Senior CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will lead and execute CQV deliverables associated with upstream and downstream GMP-regulated process equipment, utilities, automation systems, cleanrooms, and manufacturing operations.

This role requires hands-on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The Senior CQV Engineer will work cross-functionally with Engineering, Quality, Manufacturing, Automation, and external vendors to ensure successful project execution and operational readiness within fast-paced life sciences environments.


Key Responsibilities
  • Lead and execute CQV activities for pharmaceutical and biotech capital projects. 
  • Develop and execute: 
    • Commissioning plans 
    • IQ/OQ/PQ protocols 
    • Validation test scripts 
    • Traceability matrices 
    • Summary reports 
  • Support startup and qualification of: 
    • Process equipment 
    • Clean utilities 
    • HVAC systems 
    • Manufacturing suites 
    • Automation and control systems 
  • Coordinate field execution activities with engineering, construction, vendors, and operations teams. 
  • Perform system walkdowns and turnover package reviews. 
  • Support deviation investigations, CAPAs, and change control activities. 
  • Ensure all validation documentation complies with cGMP, FDA, ISPE, and GAMP guidelines. 
  • Participate in FAT/SAT execution and acceptance activities. 
  • Support project schedule development and milestone tracking. 
  • Collaborate with Quality Assurance and Manufacturing teams to support inspection readiness and successful system release. 
  • Mentor junior CQV engineers and validation specialists as needed.

Required Qualifications
  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline. 
  • 5-10+ years of CQV, validation, or pharmaceutical engineering experience within GMP-regulated environments. 
  • Strong knowledge of: 
    • cGMP regulations 
    • FDA validation requirements 
    • ISPE Baseline Guides 
    • GAMP 5 principles 
  • Experience executing commissioning and qualification for: 
    • Process equipment 
    • Utilities 
    • HVAC systems 
    • Cleanrooms 
    • Automation systems 
  • Experience authoring and reviewing validation lifecycle documentation. 
  • Strong technical writing and documentation skills. 
  • Ability to work independently within fast-paced project environments. 

Preferred Qualifications
  • Experience in biologics, sterile manufacturing, fill-finish, or aseptic processing environments. 
  • Previous consulting experience within life sciences industries preferred. 
  • Familiarity with: 
    • DeltaV 
    • MES systems 
    • SCADA platforms 
    • Kneat or electronic validation systems 
  • PMP certification or equivalent project leadership experience is a plus. 
  • Strong client-facing communication and leadership skills. 

Additional Skills & Competencies
  • Excellent organizational and multitasking abilities 
  • Strong problem-solving and analytical skills 
  • Ability to manage multiple priorities and deadlines 
  • Comfortable working in both office and field environments 
  • Ability to travel to client sites as required

________________________________________________________________________________________________


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: FULL_TIME

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