Steriles University Training Specialist III
Core
Design and deliver cGMP Steriles Manufacturing and Device Assembly Manufacturing training for new hires using Virtual Reality, instructor-led sessions, and LMS to ensure regulatory compliance.
Role type
Senior Training Specialist (cGMP Steriles Manufacturing)
Builds
Introductory cGMP training curriculums and instructional modules for sterile injectable and oral solid dose drug product environments
Domain
Life Sciences / Pharmaceutical Manufacturing / Regulatory Compliance
Required skills
Instructional design, cGMP steriles manufacturing knowledge, LMS administration, training program development, regulatory compliance monitoring, project management, adult learning coaching, cross-functional collaboration, technical documentation, assessment administration
Preferred skills
Device assembly manufacturing expertise, 7+ years in steriles manufacturing across 3 process areas, advanced project leadership, stakeholder management
Technologies
Virtual Reality platforms, Learning Management Systems (LMS), Microsoft Office applications, professional documentation and training development authoring tools
Responsibilities
Facilitate classroom training for new hires and annual refreshers; Design and develop eLearning and On the Job Training materials; Maintain up-to-date knowledge of industry and regulatory trends; Lead semi-annual reviews of training materials with leadership; Host corporate and educational site tours; Administer training assessments to identify learning gaps; Partner with Subject Matter Experts to develop consistent training programs; Document and report training outcomes to management.
Seniority
Senior, hands-on IC with strategic program ownership