Cleaning Validation Specialist

Company Overview

Viatris is a global healthcare organization bridging the gap between generic and branded medicines to more comprehensively address healthcare needs worldwide. Its mission involves empowering people throughout all stages of life with access to high-quality medicines, serving around one billion patients annually and covering conditions from acute to chronic.

Role Overview

This position within Manufacturing Science and Technology focuses on applying technical expertise to support manufacturing operations through cleaning validation and quality assurance activities. The Cleaning Validation Specialist will play a pivotal role in ensuring product quality and compliance by managing cleaning validation procedures and supporting investigations, process improvements, and product transfers.

Key Responsibilities

• Serve as Subject Matter Expert (SME) for cleaning validation at the facility.
• Plan, coordinate, and execute cleaning validation tasks including standard annual activities and clean/dirty hold time studies.
• Create and maintain the cleaning validation matrix for a multi-product manufacturing site.
• Develop, review, and prepare cleaning validation documentation such as protocols, reports, and annual reviews.
• Support and coordinate quality investigations related to manufacturing deviations and product impacts.
• Contribute to new product introduction and product transfers by providing technical validation expertise.
• Analyze technical data from varied sources systematically to identify opportunities for reducing product variability and improving processes.
• Apply quality by design principles to design experiments and scientific protocols addressing manufacturing issues.
• Demonstrate strong technical writing skills to produce high-quality scientific reports and provide recommendations.
• Work collaboratively across internal and external teams to develop innovative solutions to complex challenges.
• Support continuous process verification initiatives and collaborate with relevant functions to manage observed trends.
• Exhibit motivation and flexibility, managing tasks independently and mentoring team members.
• Communicate clearly and effectively to exchange ideas concisely and logically.
• Show strong teamwork and influencing capabilities across various functions on and off site.
• Maintain a continuous improvement mindset with a positive, can-do attitude.

Qualification Requirements

• Bachelor's degree in a scientific discipline with a minimum of three years of pharmaceutical industry or academic experience; sterile facility experience is favorable.
• Demonstrated experience working in cleaning validation within pharmaceutical manufacturing.
• Proficient knowledge of cleaning validation principles including swab and rinse sampling techniques, and Maximum Allowable Carryover (MACO) methodology.

Additional Information

Viatris offers competitive remuneration, comprehensive benefits, and a diverse and inclusive workplace where employees can leverage their unique skills and backgrounds to positively impact patient lives globally. The company is committed to equal opportunity employment.