CSV Engineer

Creative Solutions Services, LLC; Boston (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Creative Solutions Services, LLC is seeking experienced CSV Engineers 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 priorities require.

You will support validation documentation and execution, assess computerized systems against GMP, and document test results while working cross-functionally with Quality, Engineering,

Qualifications

• Approximately 5–10 years of validation experience within GMP-regulated environments.
• Strong CSV validation experience.
• Experience validating GMP computerized systems.
• Knowledge of the CSV lifecycle: planning, requirements, risk assessment, testing, traceability, and documentation.
• Understanding of data integrity and GMP expectations for computerized systems.
• Equipment validation / CQV experience in addition to CSV.
• Ability to document results and investigate discrepancies.
• Ability to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
• ValGensis is a plus.

Responsibilities

• Provide onsite validation support in a regulated biopharmaceutical manufacturing environment.
• Support validation documentation and execution activities.
• Assess computerized systems against GMP requirements.
• Execute approved validation protocols and document test results.
• Investigate discrepancies and report findings.
• Collaborate with Quality, Engineering, Manufacturing, IT, and system owners.

Skills

CSV validation

GMP validation

Data integrity

Risk assessment

Test documentation

Cross-functional collaboration

Tools

ValGensis

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.

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.