Manufacturing Quality Engineer (Nights)
Core
Support the start-up and operational readiness of a new oligonucleotide manufacturing facility by ensuring process, data, and product quality within a cGMP-regulated environment.
Role type
Manufacturing Quality Engineer (Associate)
Builds
Oligonucleotide production facility
Domain
Pharmaceutical manufacturing
Required skills
cGMP compliance, batch record review, GMP documentation review, quality system management (deviations, CAPAs, change controls), cross-functional collaboration, electronic quality systems (SAP, LIMS)
Preferred skills
Pharmaceutical/biopharmaceutical manufacturing experience, SAP/LIMS/BMRAM systems, start-up/commissioning/validation experience, Shipping & Receiving support
Technologies
SAP, LIMS, BMRAM
Responsibilities
Review and approve quality-related documentation; support batch record review and CGMP compliance; partner with Materials Management for material receipt and disposition; support validation, change control, nonconformance investigations, and CAPA activities; maintain accurate documentation in electronic quality systems.
Seniority
Associate, entry-level IC
