Teams at KBI Biopharma

Support the Computer Systems Validation lifecycle: author protocols, test scripts, execute testing, analyze/verify data, and write summary reports. Maintain validation archives, ensure compliance with 21 CFR Part 11 and EU Annex 11, support change controls, deviations, CAPAs, and audit responses, and coordinate validation for equipment and software systems.

Develop and write technically detailed proposals and project plans for biotherapeutic process development, analytics, and GMP manufacturing. Collaborate with cross-functional SMEs and BD to define scope, schedules, budgets, and deliverables; manage proposal workflow, client meetings, RFIs/RFPs, and a centralized knowledge database. Ensure accuracy, quality, and timely delivery of proposals aligned to KBI standards.

Write and edit detailed technical proposals and project plans for contract process development, analytics, and GMP biotherapeutics manufacturing. Collaborate with cross-functional SMEs to define scope, schedule, costs, and deliverables; ensure accuracy of pricing and timelines; manage RFI/RFP responses and a centralized knowledge database; represent KBI in client meetings; and meet proposal deadlines while maintaining quality and alignment with internal standards.