... method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. Documents prepared by the validation specialist must be approved by ...
... method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. Documents prepared by the validation specialist must be approved by ...
Validation Engineer I
Rockville, MD · On-site
... method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. Documents prepared by the validation specialist must be approved by ...
Validation Engineer I
Rockville, MD · On-site
... method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. Documents prepared by the validation specialist must be approved by ...
Support inventory analysis to define the scope of remediation across Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), and In-Process Monitoring (IPM) by ...
Quick apply
Support inventory analysis to define the scope of remediation across Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), and In-Process Monitoring (IPM) by ...
Validation Specialist
Dorado, PR · On-site
OQ (Operational Qualification), PQ (Performance Qualification), TMV (Test Method Validation) and IPM (In-Process Monitoring). * Apply technical judgment to: Confirm applicability of validation ...
Validation Specialist
Dorado, PR · On-site
OQ (Operational Qualification), PQ (Performance Qualification), TMV (Test Method Validation) and IPM (In-Process Monitoring). * Apply technical judgment to: Confirm applicability of validation ...
Validation Specialist
Dorado, PR · On-site
OQ (Operational Qualification), PQ (Performance Qualification), TMV (Test Method Validation) and IPM (In-Process Monitoring). * Apply technical judgment to: Confirm applicability of validation ...
Validation Specialist
Dorado, PR · On-site
OQ (Operational Qualification), PQ (Performance Qualification), TMV (Test Method Validation) and IPM (In-Process Monitoring). * Apply technical judgment to: Confirm applicability of validation ...
Qualification & Validation Specialist
Wilmington, MA · On-site
$60K - $100K/yr
... Support method validation and process validation documentation • Maintain inspection-ready validation records Expansion Project Management • Own and maintain the expansion Gantt (tasks ...
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Qualification & Validation Specialist
Wilmington, MA · On-site
$60K - $100K/yr
... Support method validation and process validation documentation • Maintain inspection-ready validation records Expansion Project Management • Own and maintain the expansion Gantt (tasks ...
... Support method validation and process validation documentation • Maintain inspection-ready validation records Expansion Project Management • Own and maintain the expansion Gantt (tasks ...
... Support method validation and process validation documentation • Maintain inspection-ready validation records Expansion Project Management • Own and maintain the expansion Gantt (tasks ...
Plan and execute test method validation activities, including assessing accuracy, precision, and repeatability * Ensure all testing and documentation aligns with Good Laboratory Practice (GLP) and ...
Plan and execute test method validation activities, including assessing accuracy, precision, and repeatability * Ensure all testing and documentation aligns with Good Laboratory Practice (GLP) and ...
Process Validation Engineer
Warsaw, IN · On-site
Perform equipment IQ/OQ, process OQ/PQ, test method validation, and Gage R&R studies. * Ensure regulatory compliance with FDA QSR, ISO 13485, and internal quality system requirements; participate in ...
Process Validation Engineer
Warsaw, IN · On-site
Perform equipment IQ/OQ, process OQ/PQ, test method validation, and Gage R&R studies. * Ensure regulatory compliance with FDA QSR, ISO 13485, and internal quality system requirements; participate in ...
Perform test method validation and measurement system analysis (e.g., Gauge R&R) * Provide Quality oversight for validation documentation and approvals * Support deviation investigations, root cause ...
Quick apply
Perform test method validation and measurement system analysis (e.g., Gauge R&R) * Provide Quality oversight for validation documentation and approvals * Support deviation investigations, root cause ...
Manager I, Validation
$101.40K - $154.65K/yr
Oversee validation activities including IQ/OQ/PQ, method validation, process validation, and computerized system validation (CSV). * Review and approve validation protocols, reports, calibration ...
Manager I, Validation
$101.40K - $154.65K/yr
Oversee validation activities including IQ/OQ/PQ, method validation, process validation, and computerized system validation (CSV). * Review and approve validation protocols, reports, calibration ...
Manager I, Validation
Rockville, MD · On-site
$101.40K - $154.65K/yr
Oversee validation activities including IQ/OQ/PQ, method validation, process validation, and computerized system validation (CSV). * Review and approve validation protocols, reports, calibration ...
Manager I, Validation
Rockville, MD · On-site
$101.40K - $154.65K/yr
Oversee validation activities including IQ/OQ/PQ, method validation, process validation, and computerized system validation (CSV). * Review and approve validation protocols, reports, calibration ...
Manager I, Validation
$101.40K - $154.65K/yr
Oversee validation activities including IQ/OQ/PQ, method validation, process validation, and computerized system validation (CSV). * Review and approve validation protocols, reports, calibration ...
Manager I, Validation
$101.40K - $154.65K/yr
Oversee validation activities including IQ/OQ/PQ, method validation, process validation, and computerized system validation (CSV). * Review and approve validation protocols, reports, calibration ...
Validation Engineer III
Centre, AL · On-site
... method validation and process validation. * Writes and/or revises IQ, OQ, PQ related documents, including any or all of the following: SOP's, validation master plans, guidelines and execution plans ...
Validation Engineer III
Centre, AL · On-site
... method validation and process validation. * Writes and/or revises IQ, OQ, PQ related documents, including any or all of the following: SOP's, validation master plans, guidelines and execution plans ...
Bacterial endotoxin test method validation and monitoring Bioburden test method validation and monitoring Radiation sterilization validation and dose audit management Ethylene oxide sterilization ...
Bacterial endotoxin test method validation and monitoring Bioburden test method validation and monitoring Radiation sterilization validation and dose audit management Ethylene oxide sterilization ...
QC Scientist - Performance
San Diego, CA · On-site
Method Validation, Antigen Release and Stability, QC Raw Materials (QCRM), QC Microbial (including seedstock) and QC Equipment/eSystems programs. The Scientist should have expertise in analytical ...
QC Scientist - Performance
San Diego, CA · On-site
Method Validation, Antigen Release and Stability, QC Raw Materials (QCRM), QC Microbial (including seedstock) and QC Equipment/eSystems programs. The Scientist should have expertise in analytical ...
Bacterial endotoxin test method validation and monitoring Bioburden test method validation and monitoring Radiation sterilization validation and dose audit management Ethylene oxide sterilization ...
Bacterial endotoxin test method validation and monitoring Bioburden test method validation and monitoring Radiation sterilization validation and dose audit management Ethylene oxide sterilization ...
Engineer, Test Method/Studies Development (JP13694)
Thousand Oaks, CA · On-site
$37 - $41/hr
Method Validation: Meet with stakeholders to gather user needs, test parameters and requirements Create and review test procedures, data, and reports. Develop test studies using existing ...
Engineer, Test Method/Studies Development (JP13694)
Thousand Oaks, CA · On-site
$37 - $41/hr
Method Validation: Meet with stakeholders to gather user needs, test parameters and requirements Create and review test procedures, data, and reports. Develop test studies using existing ...
Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g ... Run Test Method Validations * Gage R&R experience, and Risk Analysis Gage R&R * Compose protocol ...
Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g ... Run Test Method Validations * Gage R&R experience, and Risk Analysis Gage R&R * Compose protocol ...
Scientist II
Rochester, NY · On-site
Perform method validations by executing particle size testing. * Troubleshooting instrument and method problems. * Demonstrate understanding and effective use of statistical quality control ...
Scientist II
Rochester, NY · On-site
Perform method validations by executing particle size testing. * Troubleshooting instrument and method problems. * Demonstrate understanding and effective use of statistical quality control ...
Method Validation information
See salary details
$22.60 - $27.64
2% of jobs
$27.64 - $32.69
6% of jobs
$32.69 - $37.74
13% of jobs
$39.32 is the 25th percentile. Wages below this are outliers.
$37.74 - $42.79
13% of jobs
$42.79 - $47.84
11% of jobs
The median wage is $50.36 / hr.
$47.84 - $52.88
12% of jobs
$52.88 - $57.93
9% of jobs
$61.82 is the 75th percentile. Wages above this are outliers.
$57.93 - $62.98
13% of jobs
$62.98 - $68.03
13% of jobs
$68.03 - $73.08
6% of jobs
$73.08 - $78.13
3% of jobs
$22
$51
$78
How much do method validation jobs pay per hour?
What is a Method Validation job?
What are the key skills and qualifications needed to thrive in the Method Validation position, and why are they important?
What types of projects or tasks are typically involved in a Method Validation role?

Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 17 days ago
Job description
Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation specialists will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. The validation specialist will evaluate the equipment/utility/system/procedures used in development, production, and holding of pharmaceutical products and determine a validation approach. The individual should have experience with current US and international regulations, guidance, industry best practice in one of the following areas of validation: facilities, utilities, and equipment qualifications, process validation, analytical method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. Documents prepared by the validation specialist must be approved by the client. Responsibilities include:
- Interact with clients and works closely with site manufacturing, engineering, and QA to develop validation documents.
- Travel to various client sites and work independently to complete tasks.
- Provide qualification and validation services for cGMP manufacturing equipment, systems, and utilities at client sites.
- Exposure to validation aspects of facility start-up, redesign/retrofit, and expansion.
- Writes and executes qualification protocols for a variety of biopharmaceutical equipment and support utilities in accordance with SOPs, master plans, regulatory expectations, and industry standards.
- Conducts temperature mapping studies, including the operation of kaye dataloggers, or equivalent.
- Review and approve documented test results and maintain records for later analysis.
- Assist with non-conformances, investigations, and troubleshooting of equipment, utilities, and systems.
- Able to read P&IDs, isometric drawings, and As-built drawings.
Skill Level and Requirements:
- Ability to problem solve and troubleshoot.
- Technical writing ability and use of Microsoft Word, Excel, Power point, and Project
- Experience with validation equipment such as the Kaye validator, wireless data loggers, or other monitoring devices is strongly desired.
- Experience using statistical tools is a plus to analyze data captured during validation studies.
Minimum Requirements:
- BS in a technical discipline (Engineering, chemistry, microbiology, biology)
- 0-2 years of experience in at least one of the following areas: equipment/utility qualifications, process validation, analytical method validation, or cleaning validation.
- Current driver's license and auto insurance
Quality Agents offers a full suite of benefits for full-time employees including:
- Health, dental and vision insurance
- Life, AD&D and disability Insurance
- Health savings account for participants in our health plan
- 401k retirement plan
- Paid time off
- Paid holidays
Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.
Equal Opportunity & Accessibility Statement
Quality Agents, LLC is an equal opportunity employer. We make employment decisions without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other protected characteristic under applicable law. We are committed to providing reasonable accommodations for individuals with disabilities throughout the application and hiring process. If you require assistance or accommodation, please contact us.
About Quality Agents
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
11 - 50 Employees
Headquarters location
Wilmington, NC, US
Year founded
2010