CSV Engineer

Katalyst-Healthcares-; Grand Forks (ND); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking experienced CSV Engineers to deliver onsite validation support in a regulated biopharmaceutical manufacturing environment. The role centers on Computer System Validation and also encompasses equipment qualification and CQV as priorities based on project needs.

The team will validate GMP computerized systems, document results, investigate discrepancies, and coordinate with Quality, Engineering, Manufacturing, Automation and IT to ensure compliance and

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.

Responsibilities

• Provide onsite validation support for CSV projects in a regulated environment.
• Assist with validation documentation, testing, and protocol execution.
• Assess computerized systems against GMP requirements and document results.
• Collaborate with Quality, Engineering, Manufacturing, IT and system owners across multiple validation workstreams.

Skills

CSV expertise

GMP knowledge

Validation lifecycle

Cross-functional teamwork

Documentation

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.