CSV Validation Engineer – GMP Systems & CQV Expert

Katalyst-Healthcares-; South Bend (IN); On-site; USD 90,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC seeks experienced CSV Engineers for onsite validation support in a regulated biopharmaceutical manufacturing environment. The role focuses on Computer System Validation, with additional CQV and equipment validation tasks as priorities evolve.

Responsibilities include documenting test results, executing validation protocols, assessing computerized systems against GMP requirements, investigating discrepancies, and working across Quality, Engineering, Manufacturing,

Qualifications

• Approximately 5–10 years of validation experience in GMP environments.
• Strong CSV experience in regulated settings.
• Experience validating GMP computerized systems.
• Familiarity with CSV lifecycle: planning, requirements, risk, testing, traceability, validation docs.
• Understanding data integrity and GMP expectations for computerized systems.
• Equipment validation/CQV experience adds value.

Responsibilities

• Provide onsite validation support within a regulated biopharmaceutical manufacturing environment.
• Support validation docs, execution activities, and testing against GMP requirements.
• Document results, investigate discrepancies, and maintain traceability.
• Collaborate cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
• Contribute to multiple validation workstreams in a fast-moving project.

Skills

CSV/Life Science Validation

GMP/Regulated Environment

CQV

Requirements Traceability

Documentation & Testing

Cross-functional Collaboration

Tools

IQ/OQ/PQ

Validation Protocols

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.