Cleaning Validation Specialist

Responsibilities

• Act as the Subject Matter Expert (SME) for the facility regarding cleaning validation.
• Coordinate and execute cleaning validation activities, including standard yearly activities and clean/dirty hold times.
• Develop and maintain the cleaning validation matrix for a multi-product facility.
• Prepare cleaning validation documentation, including protocols, reports, and annual reviews.
• Support manufacturing through technical risk assessments, change management, and scientific investigations.
• Provide technical support for new product introductions and product transfers.
• Analyze technical data from multiple sources to identify improvement opportunities and reduce product variability.
• Participate in manufacturing quality investigations and product impact assessments.

Requirements

• Degree in a science discipline.
• At least 3 years of pharmaceutical experience (academic or industry experience is acceptable).
• Proven working experience in cleaning validation.
• Working knowledge of cleaning validation concepts, including swab/rinse sampling procedures.
• Proficiency in Maximum Allowable Carryover (MACO) methodology.
• Strong technical writing skills for creating scientific protocols and reports.

Preferred Qualifications

• Experience working within a sterile manufacturing facility.

About the Company

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands. Our mission is to empower people worldwide to live healthier at every stage of life by providing access to high-quality, affordable medicines at scale.