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Validation manager skills for your resume and career

Updated January 8, 2025

6 min read

Below we've compiled a list of the most critical validation manager skills. We ranked the top skills for validation managers based on the percentage of resumes they appeared on. For example, 6.8% of validation manager resumes contained project management as a skill. Continue reading to find out what skills a validation manager needs to be successful in the workplace.

15 validation manager skills for your resume and career

1. Project Management

Here's how validation managers use project management:

Reviewed & approved Engineering Product Specifications, Software Requirements Specifications, Project Management Plans, Design Descriptions, etc.
Project Management activities of routing, reporting, coordinating and communicating with senior management.

2. QC

Quality control is a set of instructions or procedures to ensure a manufactured product or a service is up to the highest quality standards. This set of quality control criteria are either defined by the clients or the company itself.

Here's how validation managers use qc:

Designed and Implemented Failure Analysis Process for the instrument QC failures.
Set Metrology Policy in the areas of manufacturing, QC, QA, and R&D equipment and systems.

3. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how validation managers use fda:

Participated in FDA regulatory audits and presented validation updates.
Execute a master validation plan across a network of 33 PET manufacturing facilities to meet the needs of FDA manufacturing compliance.

4. Cleaning Validation

Here's how validation managers use cleaning validation:

Executed Process Validation, Cleaning Validation and Equipment Qualification activities for the oral liquid dosage products manufactured at the Baltimore site.
Developed a global website to share Cleaning Validation documentation, training materials and best practices and foster network collaboration.

5. Regression

Here's how validation managers use regression:

Defined the regression suite and tracked manual regression versus automated coverage.
Implemented a regression process, and managed the execution of the regression testing.

6. Regulatory Agencies

A regulatory agency is a Public Benefit Corporation (PBC) that is responsible for supervising certain human activities and controlling them to some extent. They are set up in some areas such as hospitals, law firms, and governmental setup to regulate safety standards. They prevent undue and unjust abuse of power in these setups.

Here's how validation managers use regulatory agencies:

Provide validation support during Regulatory Agencies and Corporate inspections by presenting Site Validation Program, Strategies and Protocols.
Responded to issues raised by internal and external auditors and by domestic and international regulatory agencies.

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7. Process Validation

Process validation refers to the accumulation and analysis of data, starting from the process design stage to production, which provides scientific evidence that the process can routinely deliver quality products. To develop an effective process validation strategy, you need to ensure that each of its three stages has been properly taken care of. The first stage is process design, where the processes are defined. The second stage is process qualification, where the process, which has been designed earlier, is evaluated to make sure it can reproduce reliable and consistent levels of quality. The final stage is continued process verification that involves ongoing validation to ensure the process is under control.

Here's how validation managers use process validation:

Generated Site & corresponding Equipment/Facility/Utilities/Computer/Cleaning/Process Validation Master Plans.
Process Validation Plans involving filling process, sterilization process, packaging process and shipping process for a biological device combination product.

8. QA

QA, or Quality Assurance is a procedure that entails all of the steps taken to avoid any errors in the manufacturing process or in the production of the goods that a company produces. It can also include ensuring the consistency of the services rendered. Quality assurance ensures that the quality of the service delivered to consumers meets or exceeds the promised expectations. This greatly aids in the prevention of any complications that might arise after the goods or services have been distributed. It makes sure that customers are satisfied.

Here's how validation managers use qa:

Initiated spare-components inventory in QA Lab for Sales department to use in new-customer product demonstrations.
Managed QA disposition and review of commercial stability material and conduct investigations on out-of-specification/anomalous results.

9. Risk Assessments

The process of analyzing and identifying the acts or events that have the potential to negatively affect an individual, asset, or business is called risk assessment. Risk assessments are important because they form an integral part of an organization as well as occupational safety plans

Here's how validation managers use risk assessments:

Performed risk assessments to support and defend changes to critical raw materials and supplier manufacturing processes.
Performed product and process evaluation with design engineering, risk assessments, for development and manufacturing of standard calibration gas products.

10. Validation Program

Here's how validation managers use validation program:

Established internal validation program as well as generating appropriate validation procedures for the organization.
Interfaced with appropriate regulatory inspectors (USDA, CFIA) to represent the VMC validation program & validation issues.

11. System Validation

Here's how validation managers use system validation:

Visited external partner to validate test setups and review schedules to ensure proper system validation for HW reliability was done.
Lead a group of contract validation engineers (from 2 to 5) responsible for computerized system validation.

12. GMP

GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.

Here's how validation managers use gmp:

Coordinated site training requirements, delivered GMP and technical specific training, created and managed associated metrics.
Revised and approved all commissioning books for GMP and Non-GMP systems.

13. Quality System

A quality system is an organizational structure that helps management, procedures, and processes. The quality system helps the company to achieve its goals by following the right procedures. The quality system is usually documented and is based around a manual that defines and controls the system.

Here's how validation managers use quality system:

Developed quality systems within Data Center environments through the successful execution of documentation and validation techniques.
Trained department managers and production supervisors to support the Quality System.

14. Gamp

Here's how validation managers use gamp:

Lead all activities necessary to validate delivery of IS infrastructure, applications, processes and services to GAMP v5.
Develop Validation Master Plans and validation protocols consistent with good engineering practices and current Good Automated Manufacturing Practices (GAMP).

15. Computer System

Here's how validation managers use computer system:

Facilitated implementing an enterprise wide computer systems validation policy and provided validation for global regulatory applications.
Lead Business Analyst, Compliance Responsible for ensuring computer systems and software are developed and implemented in compliance with regulatory requirements.

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List of validation manager skills to add to your resume

The most important skills for a validation manager resume and required skills for a validation manager to have include:

Project Management
QC
FDA
Cleaning Validation
Regression
Regulatory Agencies
Process Validation
QA
Risk Assessments
Validation Program
System Validation
GMP
Quality System
Gamp
Computer System
Process Equipment
Validation Procedures

IQ/OQ/PQ
Iq Oq Pq
R
Debugging
Medical Devices
ISO
Test Scripts
CAPA
Laboratory Equipment
Validation Projects
SOC
Direct Reports
Management System
CIP
Validation Strategies
GxP
Process Improvement

URS
EU
Validation Efforts
SME
Test Cases
Internal Audit
HVAC
Autoclaves
UAT
EMA
Corporate Policies
CSV
Lims
USP
Regulatory Audits

Updated January 8, 2025

Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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