5-10 years of validation experience within pharmaceutical, biotechnology, or GMP-regulated environments.
Strong Computer System Validation (CSV) expertise.
Experience with validating GMP computerized systems.
Familiarity with the CSV lifecycle, including planning and documentation.
Knowledge of data integrity and GMP standards for computerized systems.
Experience with equipment validation and CQV activities.
Ability to document validation results and discrepancies clearly.
Cross-functional collaboration skills with engineering, quality, and IT.
Responsibilities
Provide onsite validation support in biopharmaceutical manufacturing.
Focus primarily on Computer System Validation while supporting wider CQV activities.
Create and execute validation documentation and protocols.
Assess computerized systems for compliance with GMP requirements.
Document and investigate validation discrepancies as they arise.
Coordinate with cross-functional teams including Engineering and Quality.
Adapt to multiple validation workstreams in a dynamic project environment.
Benefits
Engagement in challenging projects within a regulated industry.
Opportunity to work with cutting-edge biopharmaceutical technologies.
Onsite validation experience enhancing professional expertise.
Exposure to diverse functional teams in a collaborative environment.
Full 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:
pproximately 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.
bility to execute established validation protocols and clearly document results.
Experience investigating and documenting validation discrepancies or execution issues.
bility to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
