Join AbCellera as a Compliance Engineer to enhance CQV activities in a dynamic engineering environment. Your expertise in validation will ensure the highest compliance with regulatory expectations and GMP standards.
The Compliance Engineer role is essential for the Engineering Asset Management team, focusing on executing commissioning, qualification, and validation in pharmaceutical contexts. With over three years of relevant experience, you'll lead investigations into deviations while authoring crucial documentation. This role demands a detail-oriented professional who thrives in a collaborative setting and can influence cross-functional teams.
Key Responsibilities: • Author and review CQV protocols and SOPs • Lead investigations into deviations and implement CAPA • Be a trusted voice during internal and external audits • Coordinate engineering and quality change controls • Manage engineering documentation lifecycle in e-systems