CSV Engineer

Katalyst CRO; Indianapolis (IN); On-site; USD 85,000 - 125,000; Full time

Job summary

Katalyst CRO in Indianapolis, IN seeks an experienced CSV Engineer to provide onsite validation support in a regulated biopharmaceutical manufacturing environment. The role focuses on Computer System Validation while supporting equipment qualification and broader CQV activities as project priorities require.

Consultants will document test results, assess computerized systems against GMP requirements, execute approved validation protocols, investigate discrepancies, and collaborate

Qualifications

• Approximately 5-10 years of validation experience within GMP-regulated environments.
• Strong Computer System Validation experience across lifecycle stages.
• Experience validating GMP computerized systems and CSV documentation.
• Knowledge of data integrity and GMP expectations for computerized systems.
• Ability to work cross-functionally with Quality, Engineering, Manufacturing, IT and system owners.

Responsibilities

• Provide onsite validation support within a regulated biopharmaceutical manufacturing environment.
• Lead or assist with CSV activities, equipment qualification and broader CQV tasks as priorities dictate.
• Document test results, execute validated protocols and investigate discrepancies.
• Collaborate with Engineering, Quality, Manufacturing, Automation and IT to advance validation objectives.

Skills

CSV Engineering

GMP Compliance

Validation Documentation

Cross-functional Collaboration

CQV Experience

Discrepancy Investigation

Job description

Job Description

• Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment.
• The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require.
• Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results, investigate discrepancies, and work cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.
• Candidates should be comfortable supporting multiple validation workstreams and working independently in a fast-moving project environment.

Job Description

• Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment.
• The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require.
• Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results, investigate discrepancies, and work cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.
• Candidates should be comfortable supporting multiple validation workstreams and working independently in a fast-moving project environment.

Qualifications

• Approximately 510 years of validation experience within pharmaceutical, biotechnology, biopharmaceutical, or another GMP-regulated environment.
• Strong Computer System Validation experience.
• Experience supporting validation of GMP computerized systems.
• Working knowledge of the CSV lifecycle, including validation planning, requirements, risk assessment, testing/protocol execution, traceability, and validation documentation.
• Understanding of data integrity and GMP expectations for computerized systems.
• Equipment validation / CQV experience in addition to CSV.
• Ability to execute established validation protocols and clearly document results.
• Experience investigating and documenting validation discrepancies or execution issues.Ability to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
• ValGensis is a plus.