.Johnson and Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Process Engineer MSAT SM API. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.Jnj.Com/ .For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.As a Senior Process Engineer SM API in the Manufacturing Science and Technology (MSAT) Small Molecules team in Schaffhausen, you are responsible for the manufacturing of high potent small molecule API under high containment conditions. You will drive innovation and technical, data-driven process improvements at the site while supporting the growth of the portfolio, maintaining compliance, and delivering cost and capacity improvement projects in the Schaffhausen Small Molecule business.Key Responsibilities: Lifecycle management of manufacturing small molecule API and corresponding intermediates.Develop and execute cost improvement projects and process improvement efforts.Support and lead complex non-conformance investigations, CAPA, and change control assessments.Perform change controls for the lifecycle of small molecule API.Participate in site-specific and global standardization and improvement projects as a subject matter expert.Author validation documents including statistical analyses.Active participation in internal and external inspections.Qualifications Education: Advanced degree (MS/PhD) in life sciences or engineering (organic chemistry or chemical engineering preferred).Experience and Skills:Required: At least 5+ years related experience in the pharmaceutical industry with proven field experience in the following areas:Experience in pharmaceutical manufacturing processes of Small Molecule API.Knowledge of quality assurance and regulatory compliance (cGMP and EH&S).Experience in leading complex GMP investigations.Skills: Customer focus, accountability, collaboration, and project/process management skills are required. Creative, self-motivated, proactive, and results-oriented personality with strong decision-making and problem-solving competencies. Open to new ideas and driving innovation. Excellent communication and negotiation skills.Preferred: Experience with all kinds of audits and inspections.Other: Proficient in both German and English
