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Cleaning Validation Jobs in Raleigh, NC (NOW HIRING)

MedPharm

Cleaning Validation Engineer

Durham, NC · On-site

Position Summary - The Cleaning Validation Engineer oversees the development, maintenance, and governance of MedPharm's site-wide cleaning validation program across the full product lifecycle, from ...

MedPharm

Cleaning Validation Engineer

Durham, NC · On-site

Position Summary - The Cleaning Validation Engineer oversees the development, maintenance, and governance of MedPharm's site-wide cleaning validation program across the full product lifecycle, from ...

Novartis

Validation Lead

Durham, NC

$126K - $234K/yr

Lead the site validation strategy across process, cleaning, packaging, and ongoing process and cleaning verification activities. * Own and maintain the Validation Master Plan, ensuring timely ...

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All JobsCleaning Validation JobsCleaning Validation Jobs in Raleigh, NC

Cleaning Validation information

See Raleigh, NC salary details

$35

$38

$41

How much do cleaning validation jobs pay per hour?

As of Aug 13, 2026, the average hourly pay for cleaning validation in Raleigh, NC is $38.32, according to ZipRecruiter salary data. Most workers in this role earn between $36.92 and $39.71 per hour, depending on experience, location, and employer.

What is the job description of cleaning validation?

Cleaning validation is a process used in pharmaceutical and manufacturing industries to ensure that cleaning procedures effectively remove contaminants from equipment and surfaces. The job involves developing, executing, and documenting validation protocols, performing residue testing, and ensuring compliance with regulatory standards. Skills in analytical testing, attention to detail, and knowledge of Good Manufacturing Practices (GMP) are essential for this role.

What is the difference between Cleaning Validation vs Microbiologist?

AspectCleaning ValidationMicrobiologist
Required credentialsGMP, GMP-related certifications, technical trainingBiology, microbiology degrees, certifications
Work environmentPharmaceutical, biotech manufacturing facilitiesLaboratories, research facilities, healthcare settings
Employer and industry usagePharmaceutical, biotech, food industriesHealthcare, research, environmental testing

Cleaning Validation focuses on ensuring that cleaning processes effectively remove contaminants from equipment, primarily in manufacturing settings. Microbiologists study microorganisms, their behaviors, and control methods, often working in labs. While both roles require scientific knowledge and certifications, Cleaning Validation specialists concentrate on process validation in production environments, whereas Microbiologists focus on microbial analysis and research.

How do you become a cleaning validation consultant?

To become a cleaning validation consultant, professionals typically need a background in pharmaceutical or biotech manufacturing, quality assurance, or related fields, along with knowledge of validation processes and regulatory requirements such as FDA or EMA guidelines. Gaining experience through roles in validation, quality control, or manufacturing, and obtaining certifications like ASQ Certified Quality Auditor or specific validation training, can enhance credibility. Strong analytical skills, attention to detail, and familiarity with cleaning procedures and documentation are essential for success in this role.

What does cleaning validation do?

Cleaning validation is a process used in quality assurance roles to ensure that cleaning procedures effectively remove contaminants from equipment, preventing cross-contamination and ensuring product safety. It involves testing and documenting cleaning processes, often requiring knowledge of regulatory standards and analytical methods. Proper cleaning validation helps maintain compliance and product quality in regulated industries.
What job categories do people searching Cleaning Validation jobs in Raleigh, NC look for? The top searched job categories for Cleaning Validation jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Cleaning Validation jobs? Cities near Raleigh, NC with the most Cleaning Validation job openings:
Cleaning Validation jobs near you
Infographic showing various Cleaning Validation job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 66% Full Time, 29% Part Time, 1% Temporary, 2% Contract, and 1% Nights. Highlights an 100% Physical job distribution, with an average salary of $79,710 per year, or $38.3 per hour.

Cleaning Validation Engineer

MedPharm

Durham, NC • On-site

Full-time

Posted 28 days ago

Job description

Position Summary – The Cleaning Validation Engineer oversees the development, maintenance, and governance of MedPharm’s site-wide cleaning validation program across the full product lifecycle, from development through commercialization, ensuring compliance with cGMP, FDA, and global regulatory requirements.
Supporting MedPharm’s growth into a late-stage, commercialization-focused CDMO, this role provides technical leadership, risk-based strategy, and operational discipline to ensure inspection readiness, prevent cross-contamination in a multi-product environment, and optimize manufacturing throughput. The role serves as an SME in CIP, COP, and manual cleaning processes, driving robust, efficient, and compliant validation strategies aligned with client expectations and business growth.
Essential Functions
Cleaning Validation Program Ownership & Strategy
  • 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)
  • Define MACO and PDE-based acceptance limits using risk- and toxicology-based approaches
Validation Execution & Technical Leadership
  • Author, review, and approve validation protocols and reports (including IQ/OQ/PQ as applicable)
  • Design and execute validation studies (swab/rinse sampling, recovery studies, riboflavin coverage, CHT/DHT/CEHT)
  • Develop risk-based sampling strategies and worst-case scenarios based on equipment and contamination risk
  • Lead CQV activities for CIP, COP, parts washers, and manual cleaning systems
Cleaning Optimization & Troubleshooting
  • Optimize cleaning cycles using key parameters (flow, temperature, detergent, contact time)
  • Perform system performance analysis (spray coverage, flow distribution, conductivity return)
  • Investigate failures (TOC, residues, riboflavin) and implement CAPAs
  • Apply data-driven and DOE approaches to improve consistency and effectiveness
Compliance & Lifecycle Management
  • Ensure ongoing compliance through periodic review and trend analysis (TOC, conductivity, residues)
  • Support and represent cleaning validation during inspections and audits
  • Maintain inspection readiness through documentation, deviation, and CAPA management
  • Support change control and FMEA-based risk assessments
Collaboration & Training
  • Partner cross-functionally (Manufacturing, Quality, Engineering, Analytical, PM) to align strategies
  • Review GMP documentation (URS, FRS, P&IDs, equipment designs)
  • Train staff on cleaning procedures, inspection expectations, and sampling
  • Provide mentorship and technical leadership within the function
Standardization & Continuous Improvement
  • Develop and maintain SOPs, templates, and validation procedures
  • Drive standardization of cleaning validation practices
  • Implement improvements to enhance efficiency, consistency, and risk control

Supervisory responsibilities:
  • May provide technical leadership and mentorship to junior validation engineers or contractors
  • Lead training initiatives related to cleaning validation processes and compliance

Key Relationships:
  • Manufacturing Operations
  • Quality Assurance & Quality Control
  • Analytical Development / Laboratories
  • Engineering & Facilities
  • Project Management
  • Regulatory Affairs
  • Clients / External Auditors
Travel requirements:
  • Minimal travel required; occasional travel for client meetings, audits, or regulatory inspections
Education and Experience
  • Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, or related discipline)
  • 5–8+ years of experience in cleaning validation and CQV within pharmaceutical, biopharmaceutical, or CDMO environments
  • Strong experience in multi-product GMP manufacturing environments, preferably including topical, semi-solid, or aseptic/fill-finish operations
  • Demonstrated experience supporting regulatory inspections and lifecycle cleaning validation programs
Knowledge, Skills, and Abilities
  • Subject matter expertise in Cleaning Validation (CIP, COP, manual cleaning systems) and lifecycle validation
  • Strong knowledge of regulatory requirements (FDA, cGMP, ICH Q9, ASTM E2500, EU Annex 1, GAMP 5, ALCOA+)
  • Expertise in:
    • MACO & PDE calculations and toxicological risk assessments
    • Cleaning cycle development, optimization, and troubleshooting
    • Swab and rinse sampling strategies and recovery studies
    • Cross-contamination control strategies in multi-product facilities
    • Data analysis and trending (TOC, conductivity, residue monitoring)
  • Experience with:
    • CIP system performance analysis (flow dynamics, spray coverage, conductivity return)
    • Equipment qualification (IQ/OQ/PQ) and utilities (WFI, clean steam, HVAC)
    • Cleaning validation for process, fill-finish, and packaging equipment
  • Strong technical writing skills for protocols, reports, and SOPs
  • Excellent problem-solving and root-cause analysis capabilities
  • Ability to manage multiple priorities in a fast-paced, growth-oriented environment
  • Strong communication and cross-functional collaboration skills

Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position:
  • May be required to stand for extended periods within manufacturing environments
  • Occasional lifting of materials or equipment (up to 20 kg)
  • Exposure to GMP manufacturing areas including cleanrooms, laboratories, and production suites
  • May be exposed to varying temperatures, chemicals, and moderate noise levels in manufacturing settings

Other Duties 
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
 

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