5-10 years of validation experience in pharmaceutical or GMP-regulated settings.
Strong expertise in Computer System Validation (CSV).
Proficient in validating GMP computerized systems.
Knowledge of the entire CSV lifecycle, from planning to documentation.
Familiarity with data integrity standards in GMP contexts.
Experience in equipment validation/CQV in addition to CSV activities.
Capable of executing validation protocols and documenting results accurately.
Skilled at investigating and resolving validation discrepancies.
Ability to collaborate with diverse teams including Quality, Engineering, and IT.
ValGensis experience is advantageous.
Responsibilities
Provide onsite validation support in biopharmaceutical manufacturing environments.
Focus primarily on Computer System Validation activities.
Assist in equipment qualification and other CQV tasks as necessary.
Draft and execute validation documentation and protocols.
Assess computerized systems against GMP requirements.
Document test results and investigate any discrepancies.
Work collaboratively across various departments such as Quality, Manufacturing, and IT.
Benefits
Opportunity to work in a fast-paced project environment.
Engagement in critical activities within the biopharmaceutical industry.
Cross-functional collaboration with various engineering and quality teams.
Potential for professional growth in GMP and CSV expertise.
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.
