5-10 years of validation experience in a GMP-regulated environment (pharmaceuticals, biopharmaceuticals, etc.)
Strong expertise in Computer System Validation (CSV)
Experience with GMP computerized systems validation
Knowledge of the CSV lifecycle: planning, risk assessment, testing, and documentation
Understanding of data integrity and GMP standards
Experience in equipment validation and CQV alongside CSV
Proficient in executing validation protocols and documenting results
Skills in investigating validation discrepancies and execution issues
Experience working collaboratively with various departments (Quality, Engineering, IT, etc.)
Familiarity with ValGensis is advantageous.
Responsibilities
Provide onsite validation support in a biopharmaceutical manufacturing setting
Focus on Computer System Validation and support equipment qualification
Assess computerized systems compliance with GMP standards
Execute approved validation protocols and document test outcomes
Investigate any discrepancies and report findings accordingly
Collaborate cross-functionally with Engineering, Quality, Manufacturing, and IT teams
Support multiple validation workstreams in a dynamic project environment.
Benefits
Opportunity to work in a regulated biopharmaceutical environment
Engagement in critical validation activities across diverse teams
Professional development potential in the growing field of biopharmaceuticals
Collaborative workplace culture that fosters interdepartmental communication.
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:
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.
