Senior Project Engineer
Core
Managing engineering projects for CGMP manufacturing suites and capital portfolios in an FDA-regulated gene therapy facility.
Role type
Senior Project Engineer (Facilities & Engineering)
Builds
Manufacturing suites, fill/finish lines, testing labs, and cold storage warehousing for AAV and viral vector-based therapies.
Domain
Biopharmaceutical manufacturing / Gene Therapies
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project scheduling, capital project management, regulatory documentation (Deviations, SOPs, Change Controls), stakeholder coordination, technical writing, mechanical space navigation, PPE usage
Preferred skills
Six Sigma Green Belt or Black Belt certification, knowledge of pharmaceutical regulatory requirements
Technologies
Project tracking software
Responsibilities
Prepare project reports, manage invoices and purchase orders, follow up on execution of regulatory documents, manage scheduling of multiple engineering projects, coordinate with schedulers and stakeholders, act as main point of contact for deliverables, create project scopes aligned with business objectives, maintain detailed project schedules, schedule and maintain vendors onsite
Seniority
Senior, hands-on IC
