Sr. CSV Engineer

Katalyst CRO; Chesterbrook (PA); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking a Senior CSV Engineer with 10+ years of pharmaceutical compliance, CSV, and GxP experience. The role covers regulatory alignment with 21 CFR Part 11, GxP, GAMP 5, and SOX IT, plus quality, document, and change management expertise.

Responsibilities include validating processes, primary packaging validation, cleaning validation, and creating validation plans. Global client exposure and strong stakeholder communication are required.

Qualifications

• 10+ years of experience in pharmaceutical compliance, Computerized System Validation (CSV), and GxP-regulated environments.
• Expertise in compliance regulations including 21 CFR Part 11, GxP, GAMP 5, SOX IT, Quality Management, Document Management, and Change Management.
• Experience with testing tools such as Client-ALM, JIRA, X-Ray, Agile methodologies, and exposure to global delivery models is required.
• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5 and SOX IT.
• Subject matter expertise in areas such as Quality Management, Document Management, and Change Management.
• Establish, implement, and monitor quality management requirements to ensure IT projects meet Quality and Regulatory requirements.
• Knowledge of various testing tools used throughout the pharmaceutical industry.
• Must have global client exposure and experience working in a global delivery model.
• Experience with Client-ALM, JIRA, X-Ray, and Agile methodologies.

Responsibilities

• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5 and SOX IT.
• Subject matter expertise in areas such as Quality Management, Document Management, and Change Management.
• Establish, implement, and monitor quality management requirements to ensure IT projects meet Quality and Regulatory requirements.
• Knowledge of various testing tools used throughout the pharmaceutical industry.
• Must have global client exposure and experience working in a global delivery model.
• Experience with Client-ALM, JIRA, X-Ray, and Agile methodologies.
• Responsible for developing, implementing, and managing process validation, primary packaging validation, cleaning validation, and revalidation strategies to meet GxP and quality requirements on time and within budget to ensure compliance with regulatory expectations and SOPs.
• Establish and manage validation plans by aligning, coordinating, and supervising prioritization of activities against business needs.
• Set local procedures and templates for validation documentation and validation master plans.
• Develop, achieve approval for, and publish validation schedules.
• Create and maintain the overall board validation plan.
• Good communication and stakeholder management skills.

Skills

Compliance regulations

Quality Management

Document Management

Change Management

GxP

21 CFR Part 11

GAMP 5

SOX IT

Global delivery model

Stakeholder management

Tools

Client-ALM

JIRA

X-Ray

Agile

Job description

• Seeking a Sr. CSV Engineer with 10+ years of experience in pharmaceutical compliance, Computerized System Validation (CSV), and GxP-regulated environments.


• The ideal candidate should have expertise in compliance regulations including 21 CFR Part 11, GxP, GAMP 5, SOX IT, Quality Management, Document Management, and Change Management.


• Experience with testing tools such as Client-ALM, JIRA, X-Ray, Agile methodologies, and exposure to global delivery models is required.


• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5 and SOX IT.


• Subject matter expertise in areas such as Quality Management, Document Management, and Change Management.


• Establish, implement, and monitor quality management requirements to ensure IT projects meet Quality and Regulatory requirements.


• Knowledge of various testing tools used throughout the pharmaceutical industry.


• Must have global client exposure and experience working in a global delivery model.


• Experience with Client-ALM, JIRA, X-Ray, and Agile methodologies.


• Responsible for developing, implementing, and managing process validation, primary packaging validation, cleaning validation, and revalidation strategies to meet GxP and quality requirements on time and within budget to ensure compliance with regulatory expectations and SOPs.


• Establish and manage validation plans by aligning, coordinating, and supervising prioritization of activities against business needs.


• Set local procedures and templates for validation documentation and validation master plans.


• Develop, achieve approval for, and publish validation schedules.


• Create and maintain the overall board validation plan.


• Good communication and stakeholder management skills.

Job Summary

• Seeking a Sr. CSV Engineer with 10+ years of experience in pharmaceutical compliance, Computerized System Validation (CSV), and GxP-regulated environments.


• The ideal candidate should have expertise in compliance regulations including 21 CFR Part 11, GxP, GAMP 5, SOX IT, Quality Management, Document Management, and Change Management.


• Experience with testing tools such as Client-ALM, JIRA, X-Ray, Agile methodologies, and exposure to global delivery models is required.

Roles & Responsibilities

• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5 and SOX IT.


• Subject matter expertise in areas such as Quality Management, Document Management, and Change Management.


• Establish, implement, and monitor quality management requirements to ensure IT projects meet Quality and Regulatory requirements.


• Knowledge of various testing tools used throughout the pharmaceutical industry.


• Must have global client exposure and experience working in a global delivery model.


• Experience with Client-ALM, JIRA, X-Ray, and Agile methodologies.


• Responsible for developing, implementing, and managing process validation, primary packaging validation, cleaning validation, and revalidation strategies to meet GxP and quality requirements on time and within budget to ensure compliance with regulatory expectations and SOPs.


• Establish and manage validation plans by aligning, coordinating, and supervising prioritization of activities against business needs.


• Set local procedures and templates for validation documentation and validation master plans.


• Develop, achieve approval for, and publish validation schedules.


• Create and maintain the overall board validation plan.


• Good communication and stakeholder management skills.

Experience

• 10+ years of experience mandatory.


• Understanding of Compliance, GxP, and Lab Informatics.


• Experience in pharmaceutical, regulated, or GxP environments with Computerized System Validation (CSV).