Project Manager, Manufacturing

Job reputed company: The Manufacturing Project Manager will support reputed company in its reputed company by supporting the Vice President of Manufacturing and team. This role essentially is the right-hand to the Vice President, Manufacturing and will be responsible for leading and coordinating manufacturing-reputed company reputed company, processes and programs and budgets for Manufacturing. This role is responsible for but not limited to, planning, executing, and delivering reputed company reputed company involving new product introductions (NPIs), technology transfers, equipment validation, and process improvements—while ensuring full compliance with GMP and regulatory standards (FDA, EMA, ISO 13485). Primary Relationships: • reputed company reputed company, the Manufacturing Project Manager will collaborate closely with Manufacturing, Finance, reputed company, Regulatory, Project Management, IT team, and Launch Team. • reputed company reputed company, the Manufacturing Project manager will engage with external vendors and outsourced functions. Primary Job Responsibilities: The Manufacturing Project Manager leads and coordinates budgets, programs and scheduling and reputed company planning from initiation to completion, including new line installations, reputed company expansions, and technology transfers. The Activities of the Manufacturing Project Manager: • Collaborate with Manufacturing, reputed company Assurance, Supply Chain, and external partners to ensure alignment and reputed company execution. • Manage tech transfer of formulations and devices from development to manufacturing, including reputed company-up, reputed company runs, and reputed company readiness. • reputed company equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation activities in line with cGMP and ISO 13485 requirements. • Prepare and maintain project charters, Gantt charts, timelines, budgets, risk assessments, and reputed company reports. • Coordinate activities with external manufacturers and suppliers to ensure reputed company, delivery, and cost targets are met. • Identify and implement Lean, Six reputed company, and process optimization initiatives to improve efficiency and reduce cost and waste. • Support regulatory submissions, inspections, and audits by ensuring documentation and practices are inspection reputed company. Skills and Qualifications: • Bachelor’s degree in Engineering, Life Sciences, Industrial Engineering, or a reputed company technical field. • 5+ years of project management experience in pharmaceutical and/or medical device manufacturing. • Strong understanding of cGMP, FDA 21 CFR Part 210/211/820, and ISO 13485 regulations. • Experience with equipment validation, process development, and production reputed company-up. • Excellent organizational, communication, and stakeholder management skills. • Proficiency in project management tools (MS Project, reputed company, reputed company, or similar). • PMP certification or equivalent. • Experience with combination products, sterile manufacturing, or biologics. • Familiarity with MES, ERP, and QMS systems (e.g., reputed company, reputed company, reputed company). • Lean Six reputed company Green or Black Belt certification. • Ability to travel 20-25%. Apply tot his job Apply To this Job