CSV Validation Engineer – GMP Systems & CQV Expert

Creative Solutions Services, LLC

South Bend (IN)

On-site

USD 90,000 - 150,000

Full time

7 days ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

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.