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Validation Manager Jobs in Raleigh, NC (NOW HIRING)

Position Summary - The Cleaning Validation Engineer oversees the development, maintenance, and ... Project Management * Regulatory Affairs * Clients / External Auditors Travel requirements:

Position Summary - The Cleaning Validation Engineer oversees the development, maintenance, and ... Project Management * Regulatory Affairs * Clients / External Auditors Travel requirements

Lead and manage complex validation and technical projects. * Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations, including being on-call for ...

This individual will lead validation lifecycle activities, including protocol development, execution, deviation management, and final reporting, while ensuring compliance with cGMP, data integrity ...

This individual will lead validation lifecycle activities, including protocol development, execution, deviation management, and final reporting, while ensuring compliance with cGMP, data integrity ...

Through our expertise, insight, consulting and management skills, we accelerate breakthrough ... The Sr. Validation Engineer will serve as a subject matter expert, support complex technical ...

This individual will lead validation lifecycle activities, including protocol development, execution, deviation management, and final reporting, while ensuring compliance with cGMP, data integrity ...

... Team Management - Plan and coordinate work - Direct small teams in document development and/or execution Qualifications and Experience - Bachelor's degree in a science or engineering field (or ...

This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr. ...

Through our expertise, insight, consulting and management skills, we accelerate breakthrough ... The Sr. Validation Engineer will serve as a subject matter expert, support complex technical ...

... Team Management - Plan and coordinate work - Direct small teams in document development and/or execution Qualifications and Experience - Bachelor's degree in a science or engineering field (or ...

Showing results 21-40

Validation Manager information

See Raleigh, NC salary details

$46.2K

$102.5K

$156K

How much do validation manager jobs pay per year?

As of Aug 11, 2026, the average yearly pay for validation manager in Raleigh, NC is $102,466.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,400.00 and $128,300.00 per year, depending on experience, location, and employer.

How does a validation manager typically collaborate with other departments during project execution?

Validation Managers frequently work cross-functionally with quality assurance, manufacturing, engineering, and regulatory teams to ensure all systems and processes meet required standards. Effective collaboration involves coordinating validation protocols, sharing critical documentation, and communicating status updates to keep projects on track. A Validation Manager often leads meetings to align stakeholders, addresses compliance concerns, and resolves issues swiftly to prevent delays. Building strong relationships across departments is essential for smooth validation processes and successful project outcomes.

What is a validation manager?

A validation manager works in a manufacturing plant and oversees the proper operation of machinery and equipment. Your job duties include developing operational plans for the entire facility, identifying areas of process improvement, and scheduling periodic auditing reviews of the facility. The qualifications needed for a career as a validation manager include a bachelor’s degree in business, organizational theory, quality control, or a related field. You also need strong communication and computer skills and experience in a management position.

What are the key skills and qualifications needed to thrive as a validation manager, and why are they important?

To thrive as a Validation Manager, you need a strong background in quality assurance, regulatory compliance (such as FDA or EMA guidelines), and validation principles, usually supported by a degree in life sciences or engineering. Familiarity with validation protocols, risk management tools, and systems like GMP documentation platforms is essential. Leadership, attention to detail, and effective communication are crucial soft skills for managing teams and coordinating cross-functional projects. These skills and qualities ensure that products and processes consistently meet regulatory standards, reducing risks and ensuring compliance.

What is the difference between Validation Manager vs Quality Assurance Specialist?

AspectValidation ManagerQuality Assurance Specialist
CertificationsGxP, ISO, or industry-specific validation certificationsISO, Six Sigma, or QA-related certifications
Work EnvironmentRegulated industries like pharmaceuticals, biotech, or medical devicesManufacturing, software, or service industries
Primary FocusEnsuring validation processes for equipment, systems, and processes meet standardsMonitoring and improving overall quality processes and compliance

The Validation Manager primarily oversees validation activities to ensure compliance with industry standards, focusing on equipment and process validation. In contrast, the Quality Assurance Specialist concentrates on maintaining overall quality standards across products and services. Both roles are essential for compliance but differ in scope and responsibilities.

What are the most commonly searched types of Validation jobs in Raleigh, NC? The most popular types of Validation jobs in Raleigh, NC are:
What are popular job titles related to Validation Manager jobs in Raleigh, NC? For Validation Manager jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Validation Manager jobs in Raleigh, NC look for? The top searched job categories for Validation Manager jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Validation Manager jobs? Cities near Raleigh, NC with the most Validation Manager job openings:
Infographic showing various Validation Manager job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 15% Part Time, and 2% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $102,466 per year, or $49.3 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.