The Technical Investigations Lead ensures timely, compliant, scientifically sound investigations and drives the effectiveness of CAPAs impacting biologics operations
Job Summary
The Technical Investigations Lead ensures timely, compliant, scientifically sound investigations and drives the effectiveness of CAPAs impacting biologics operations.
This role provides daily leadership to site investigators and represents the site during internal and external audits for deviations and CAPAs.
BIOVECTRA, part of Agilent, offers opportunities to work with cutting-edge technologies and a team committed to advancing manufacturing and improving patient care.
Matching Summary
The Technical Investigations Lead ensures timely, compliant, scientifically sound investigations and drives the effectiveness of CAPAs impacting biologics operations.
Salary
Base: $31.92 - $55.86/hr CAD; Bonus/Equity: Eligible for bonus, stock; Benefits: Included
Skills & Requirements
Must-have
GMP manufacturing environment experience
Deviation and CAPA lifecycle management
Root cause analysis expertise
Cross-functional team leadership
Regulatory inspection support
Investigation workflow and RCA capability
Nice-to-have
Strong communication and facilitation skills
Technical writing and presentation skills
Knowledge of biologics and contamination control
Training and coaching investigators
Experience with upstream/downstream operations
Key Requirements
Bachelor’s degree in Science or Engineering
6+ years GMP manufacturing experience
Experience supporting FDA, Health Canada, EMA inspections
Advance degree preferred
Expertise in RCA, CAPA effectiveness, deviation management