5-10 years of experience in validation within GMP-regulated environments
Proficient in Computer System Validation methodologies
Experience with GMP computerized system validation
Knowledge of the CSV lifecycle including planning and documentation
Familiarity with data integrity and GMP expectations
Background in equipment validation and CQV activities
Skilled in executing validation protocols and documenting results
Experience in investigating validation discrepancies and execution issues
Ability to collaborate across multiple functions like Quality and Engineering
ValGensis experience is a plus
Responsibilities
Provide onsite validation support in biopharmaceutical manufacturing
Focus on Computer System Validation and equipment qualification
Support validation documentation and activity execution
Assess computerized systems against GMP standards
Execute approved validation protocols and document outcomes
Investigate discrepancies in validation processes
Work independently on multiple validation workstreams
Benefits
Opportunity to work in a fast-paced, regulated environment
Engage in cross-functional collaboration
Chance to influence quality assurance practices
Exposure to diverse validation workstreams
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.
