The role ensures test methods, equipment, and processes are compliant with regulatory requirements including method validation standards and data integrity standards
Job Summary
The role ensures test methods, equipment, and processes are compliant with regulatory requirements including method validation standards and data integrity standards.
Candidates will manage the execution of IQ/OQ/PQ protocols for new and existing laboratory instruments while representing QC in site validations.
Smith & Nephew offers a hybrid work model along with comprehensive benefits including medical, dental, vision, and a 401k matching program.
Matching Summary
The role ensures test methods, equipment, and processes are compliant with regulatory requirements including method validation standards and data integrity standards.
Skills & Requirements
Must-have
GMP-regulated laboratory environment
Test method validation execution
Equipment qualification IQ OQ PQ
Computer system validation CSV
ALCOA+ data integrity principles
Validation protocol authoring
Nice-to-have
Experience with regulatory inspections
LIMS or CDS system familiarity
Automation and system integration knowledge
Risk management tool application
Cross-functional team collaboration
Key Requirements
Bachelor's degree in Chemistry, Biology, Engineering, or related field
2-6 years experience in pharmaceutical or biotech lab environments
U.S. citizenship or permanent residency required (no sponsorship)
Work Rights
Must have US work authorization; no H1B transfer available