Strategic Operations Project Specialist
Core
Technical and project management resource supporting manufacturing readiness, process improvements, quality initiatives, and cross-functional operational projects in a cGMP environment.
Role type
Senior IC strategic operations project specialist
Builds
Manufacturing readiness, process improvements, and operational excellence initiatives
Domain
Biotechnology/Pharmaceutical manufacturing
Required skills
Project management, technical knowledge of manufacturing processes and equipment, change control management, risk assessment, continuous improvement, stakeholder management, analytical problem-solving
Preferred skills
Engineering or Life Sciences degree, experience in regulated manufacturing environments, knowledge of cGMP and quality systems, validation activities experience
Technologies
Manufacturing equipment and systems, project management tools
Responsibilities
Lead cross-functional projects for manufacturing readiness and process improvements; manage project scope, timelines, and risks; provide technical support for manufacturing processes and equipment; support technical transfers and campaign readiness; lead change control activities; develop and report KPIs; investigate operational issues; support equipment procurement and installation; represent Strategic Operations on Joint Project Teams
Seniority
Senior, hands-on IC
