Cleaning Validation Leader

vor 5 Monaten

Basel, Schweiz Novartis Vollzeit

393612BR

**Cleaning Validation Leader (M/F/d)**:
Switzerland

**About the role**

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.

**Commitment to Diversity & Inclusion**:

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

**Role Requirements**

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.

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

**Division**

Development

**Business Unit**

TECHNICAL R & D GDD

**Work Location**

Basel

**Company/Legal Entity**

Novartis Pharma AG

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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