CSV Engineer

Katalyst CRO; Boston (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO seeks experienced CSV Engineers for on-site validation support in a regulated biopharmaceutical environment. The role centers on Computer System Validation while also supporting equipment qualification and broader CQV activities as priorities require.

Consultants will validate documentation and execute protocols, assess systems against GMP requirements, document results, investigate discrepancies, and work across Engineering, Quality, Manufacturing, Automation, IT, and system owners.

Qualifications

• Approximately 5–10 years of validation experience in GMP-regulated environments.
• Strong CSV validation experience and knowledge of GMP expectations.
• Experience validating GMP computerized systems and CQV activities.

Responsibilities

• Support validation documentation and execution activities on-site.
• Assess computerized systems against GMP requirements and execute validation protocols.
• Document test results and investigate discrepancies.
• Collaborate cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.

Skills

CSV validation

GMP compliance

CQV experience

Validation lifecycle

Documentation

Cross-functional collaboration

Data integrity

Equipment validation

Root cause investigation

On-site validation

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 5-10 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.