... validation, analytical method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. Documents prepared by the ...
... validation, analytical method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. Documents prepared by the ...
Execute analytical method qualification and validation studies supporting release, stability, characterization and in process testing of cell therapy products in a GMP environment. * Independently ...
Execute analytical method qualification and validation studies supporting release, stability, characterization and in process testing of cell therapy products in a GMP environment. * Independently ...
This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations. Requirements ...
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Apply Early
This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations. Requirements ...
Apply Early
Execute analytical method qualification and validation studies supporting release, stability, characterization and in process testing of cell therapy products in a GMP environment. * Independently ...
Quick apply
Execute analytical method qualification and validation studies supporting release, stability, characterization and in process testing of cell therapy products in a GMP environment. * Independently ...
Analytical Chemist
$60.69/hr
We are seeking an experienced Senior Scientist - Method Development to support analytical method development and validation activities within a fast-paced laboratory environment. This highly ...
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Apply Early
Analytical Chemist
$60.69/hr
We are seeking an experienced Senior Scientist - Method Development to support analytical method development and validation activities within a fast-paced laboratory environment. This highly ...
Apply Early
This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations. Requirements ...
This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations. Requirements ...
The SA Chemist is responsible for analytical method development, method validation and performing chemical testing and analyses in accordance with written procedures. This work is conducted in ...
The SA Chemist is responsible for analytical method development, method validation and performing chemical testing and analyses in accordance with written procedures. This work is conducted in ...
Analytical Chemist
Waunakee, WI · On-site
The SA Chemist is responsible for analytical method development, method validation and performing chemical testing and analyses in accordance with written procedures. This work is conducted in ...
Analytical Chemist
Waunakee, WI · On-site
The SA Chemist is responsible for analytical method development, method validation and performing chemical testing and analyses in accordance with written procedures. This work is conducted in ...
The SA Chemist is responsible for analytical method development, method validation and performing chemical testing and analyses in accordance with written procedures. This work is conducted in ...
The SA Chemist is responsible for analytical method development, method validation and performing chemical testing and analyses in accordance with written procedures. This work is conducted in ...
This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations. Requirements ...
This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations. Requirements ...
Support method transfer and validation activities. Author protocols, risk assessments, and ... Train analysts and support knowledge transfer activities. Generate GMP documentation and final ...
Support method transfer and validation activities. Author protocols, risk assessments, and ... Train analysts and support knowledge transfer activities. Generate GMP documentation and final ...
Sr. Manager/Associate Director QC Scientist (Analytical-Late Stage Development & Process Excellence)
Brighton, MA · On-site
$150K - $215K/yr
Key Responsibilities Analytical Method Life Cycle Management & Validation * Lead analytical method activities to CDMOs, including transfer as appropriate, validation and authoring validation ...
Sr. Manager/Associate Director QC Scientist (Analytical-Late Stage Development & Process Excellence)
Brighton, MA · On-site
$150K - $215K/yr
Key Responsibilities Analytical Method Life Cycle Management & Validation * Lead analytical method activities to CDMOs, including transfer as appropriate, validation and authoring validation ...
This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations. • Evaluate ...
This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations. • Evaluate ...
Scientist I, AR&D
Chantilly, VA · On-site
$65K - $75K/yr
This includes performing the Assay Dissolution, analytical method development, and method validation including preparing analytical method validation and verification protocols . Additionally, you ...
Scientist I, AR&D
Chantilly, VA · On-site
$65K - $75K/yr
This includes performing the Assay Dissolution, analytical method development, and method validation including preparing analytical method validation and verification protocols . Additionally, you ...
... 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 ...
... 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 ...
Execute analytical method validation and forced degradation studies * Collect, analyze, and visualize raw data, preparing graphs and applying statistical methods (Excel, Minitab) * Prepare and review ...
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Apply Early
Execute analytical method validation and forced degradation studies * Collect, analyze, and visualize raw data, preparing graphs and applying statistical methods (Excel, Minitab) * Prepare and review ...
Apply Early
Sr. Manager/Associate Director QC Scientist (Analytical-Late Stage Development & Process Excellence)
$150K - $215K/yr
Key Responsibilities Analytical Method Life Cycle Management & Validation * Lead analytical method activities to CDMOs, including transfer as appropriate, validation and authoring validation ...
Sr. Manager/Associate Director QC Scientist (Analytical-Late Stage Development & Process Excellence)
$150K - $215K/yr
Key Responsibilities Analytical Method Life Cycle Management & Validation * Lead analytical method activities to CDMOs, including transfer as appropriate, validation and authoring validation ...
This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations. Requirements ...
This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations. Requirements ...
Validation Engineer I
Rockville, MD · On-site
... 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 ...
Validation Engineer I
Rockville, MD · On-site
... 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 ...
Scientist I, AR&D
Chantilly, VA · On-site
$65K - $75K/yr
This includes performing the Assay Dissolution, analytical method development, and method validation including preparing analytical method validation and verification protocols . Additionally, you ...
Quick apply
Apply Early
Scientist I, AR&D
Chantilly, VA · On-site
$65K - $75K/yr
This includes performing the Assay Dissolution, analytical method development, and method validation including preparing analytical method validation and verification protocols . Additionally, you ...
Apply Early
Analytical 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 analytical method validation jobs pay per hour?
What are the key skills and qualifications needed to thrive in the Analytical Method Validation position, and why are they important?
To thrive in Analytical Method Validation, you need a strong background in analytical chemistry or related sciences, precision in laboratory work, and experience with method development and validation protocols, often supported by a relevant degree. Familiarity with instrumentation such as HPLC, GC, and mass spectrometry, as well as knowledge of regulatory standards like ICH, FDA, or USP, and proficiency in laboratory information management systems (LIMS) are key. Attention to detail, critical thinking, and effective communication are important soft skills for troubleshooting and collaborating with cross-functional teams. These skills ensure robust, compliant analytical methods that underpin product quality and regulatory approval.
What is an Analytical Method Validation job?
An Analytical Method Validation job involves developing, assessing, and documenting laboratory methods to ensure they produce reliable and accurate results. Professionals in this role validate methods according to regulatory guidelines (such as ICH, USP, or FDA) by evaluating parameters like accuracy, precision, specificity, and robustness. They work in industries like pharmaceuticals, biotechnology, and chemicals to ensure compliance with quality standards. The role also requires troubleshooting analytical issues and maintaining validation records to support regulatory audits.
What does a typical day look like for someone working in Analytical Method Validation?
A typical day in Analytical Method Validation involves developing and executing protocols to verify that laboratory methods are reliable, accurate, and consistent with industry regulations. You'll spend time in the lab conducting experiments, analyzing sample data, documenting results, and preparing detailed validation reports for regulatory submission. Collaborating with quality assurance, regulatory teams, and other scientists is common to address findings and ensure alignment with project goals. This role combines hands-on technical work with critical data review and cross-disciplinary teamwork, offering a dynamic and intellectually engaging work environment.

Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 22 days ago
Job description
Quality Agents, LLC is a service company offering validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation Engineers will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. The ValidationEngineer 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 ValidationEngineermust 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)
- 2 - 5 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.
About Quality Agents
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
11 - 50 Employees
Headquarters location
Wilmington, NC, US
Year founded
2010