Senior Engineer I, CQV & Drug Product Engineering
Core
Senior individual contributor providing technical engineering leadership and hands-on support for commissioning, qualification, validation readiness, and routine GMP manufacturing operations for Drug Product Fill & Finish lines.
Role type
Senior IC manufacturing engineering specialist (CQV & Drug Product)
Builds
GMP-compliant filling lines, autoclaves, parts washers, and associated process systems for mRNA drug products
Domain
Biotechnology / Pharmaceutical manufacturing (mRNA)
Required skills
cGMP knowledge, equipment qualification (IQ/OQ/PQ), GMP documentation, aseptic processing, change control, CAPA, deviation management, root cause analysis, cross-functional coordination, technical risk evaluation, equipment lifecycle management
Preferred skills
aseptic Fill & Finish experience, PPQ readiness, media fills, temperature mapping, equipment modifications, vendor collaboration, continuous improvement initiatives, engineering change management
Technologies
GMP quality systems, electronic records systems, engineering assessment tools
Responsibilities
Support commissioning, qualification, and validation activities for GMP Drug Product manufacturing equipment; Serve as technical system owner for assigned equipment ensuring operational readiness and compliance; Provide day-to-day engineering support for aseptic Fill & Finish operations and troubleshoot equipment issues; Coordinate engineering and qualification priorities to support manufacturing schedules; Lead assigned engineering projects and qualification workstreams as an individual contributor; Support regulatory audits by providing technical documentation and subject-matter expertise.
Seniority
Senior, hands-on IC