Biopharma CSV Validation Engineer (Onsite)

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

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