CSV Engineer

Katalyst Talent Agency

Boston, MA, United States

3 days ago

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Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

5 years minimum

Working hours

Regular working hours

Job source

Data Integrity System Testing Iq/oq/pq Computerised Systems

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.

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.