CSV Engineer

JobDiva, Inc.; Indianapolis (IN); On-site; USD 110,000 - 170,000; Full time

Job summary

JobDiva, Inc. seeks experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment.

The primary focus is Computer System Validation, with equipment qualification and CQV activities as priorities. You will support validation documentation and execution, assess computerized systems against GMP requirements, execute approved validation protocols, document test results, investigate discrepancies, and work cross-functionally with

Qualifications

• Approximately 5-10 years of validation experience within GMP environments.
• Strong Computer System Validation experience.
• Experience validating GMP computerized systems.
• Knowledge of the CSV lifecycle: planning, requirements, risk assessment, testing, traceability, documentation.
• Understanding data integrity and GMP expectations for computerized systems.
• Equipment validation / CQV experience in addition to CSV.
• Ability to document results clearly 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 within a regulated biopharma manufacturing environment.
• Support validation documentation and execution activities; assess systems against GMP requirements.
• Execute validated protocols, document test results, investigate discrepancies.
• Collaborate cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.
• Support multiple validation workstreams and work independently in a fast-moving project environment.

Skills

CSV engineering

Validation execution

Cross-functional collaboration

Attention to detail

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.