(Senior) Project Engineer, MSAT QRM
Vor 2 Tagen
Job Description - (Senior) Project Engineer, MSAT QRM (2506231036W)
Description
Cilag AG, part of Johnson & Johnson, is recruiting for a MSAT QRM (Senior) Project Engineer to be located in Schaffhausen, Switzerland.
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.
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 MSAT QRM Project Engineer (80-100%) in the Manufacturing Science and Technology team in Schaffhausen, you are responsible for the integration of the defined Quality Risk Management (QRM) strategy for the site Schaffhausen. This includes the MSAT owned processes of the Large and Small Molecule business.
You will deploy and supervise the QRM process in a diverse field of stakeholders in an interdisciplinary field of business areas. This includes processes to manufacture Large Molecule Drug Products, Small Molecule Drug Products, and Small Molecule Drug Substances (API) and the corresponding intermediates. You will constantly support the risk management teams to determine the risks of these processes, and you will act as a local project lead. You will work with multi-functional teams to achieve company & department goals.
Key Responsibilities:- Maintain and implement global and local QRM processes
- Develop and execute QRM administration process as a project owner
- Support and lead complex risk management processes
- Author of QRM documents
- Overview and tracking of QRM actions
- Option for additional tasks in the field of QRM
Education:
Experience and Skills:
Required:
- You have experience in the pharmaceutical industry with a strong GMP background
- Basic knowledge in pharmaceutical manufacturing processes of Small Molecule API, Small Molecule Drug Product, and Large Molecule Drug Product
- Knowledge of quality assurance and regulatory compliance (cGMP)
- Customer Focus, Accountability, Collaboration, and Project/Process Management skills are required
- Creative teammate, self-motivated, pro-active, and results-oriented personality
- Strong decision-making and problem-solving competencies
- You question conventional thinking and are ready to influence
- You are open to new ideas and you are driving innovation
- Excellent communication and negotiation skills
- Experience with QRM process based on ICH Q9 with strong GMP background
- Proficient in both German and English
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.
Primary LocationIf you are an individual with a disability, please check our page for information on how to request an accommodation.
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