Job ID

Location: Basel, Switzerland
Role Purpose:
We are looking for a Cleaning Validation Leader to support the department Chemical & Analytical Development as part of the Global Technical R&D department of Global Drug Development. You will play a crucial role in establishing, owning and optimizing the changeover/cleaning concepts and contamination control strategies for non-sterile and low bioburden DS manufacturing facilities. We need someone with a strong background and hands on experience in Cleaning Validation and all related topics to join our team. Expertise in sterile or aseptic manufacturing operations is an asset.
Your main responsibilities:
• Responsible lead for contamination and cross-contamination control strategy for non-sterile and low bioburden DS manufacturing (may also include fully formulated DS and DP); this exhibits the current product portfolio and new product (class) introductions including ownership of relevant GxP documentation, e.g. risk assessments (HACCP, FMEA), standard operation procedures.
• Define and lead the cleaning concept, validation strategy, creation of Cleaning Validation master plan, cleaning monitoring and cleaning verification (changeover) program for multi-purpose and/or dedicated process equipment, clean rooms and systems related to synthetically manufactured products.
• Specifically, develop product decontamination methods as well as procedures and cleaning methods including efficiency assessment.
• Implement global standards and procedures, i.a. related to environmental monitoring (viable and non-viable particles), gowning, cleanliness zones, Cleaning Validation and bioburden decontamination.
• Ensure cleaning methods and practices adhere to current industry best practice, GMP and regulatory requirements; lead and initiate process (continuous) improvement projects pertaining to Cleaning Validation activities.
• Responsible lead for GMP audits and provide guidance and oversight to ensure control strategies, Cleaning Validation/verification concepts and monitoring programs are well understood, implemented, and represented to health authorities.
• Owner of change control processes as well as deviation management/root cause investigation in the established, validated GxP system in their field of duty.
• Act as main author/approver and single point of contact with relevant stakeholder (departments) in (microbiological) Cleaning Validation and monitoring activities.

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements:
• Ph.D or Master in pharmaceutical technology sciences, microbiology, pharmaceutical engineering, chemistry, chemical engineering, or related fields or similar qualification.
• Extensive experience in biotech and/or pharma industry and in-depth knowledge of cleaning assurance and issuing GxP documentation related to (cross-)contamination prevention; experience in aseptic/sterile manufacturing practices including sterility assurance is a plus.
• Solid understanding of GMP and regulatory validation requirements.
• Excellent writing skills and excellent communication skills with command of English and German, written and oral.
• Excellent leadership and interpersonal skills; proven ability as team player and ability to manage cross-functional teams.
• Excellent planning and organizing skills.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Development

TECHNICAL R & D GDD

Switzerland

Basel

Novartis Pharma AG

Research & Development

Full Time

Regular

No