Senior Cleaning Validation Specialist
Welcome to Catalent, a leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products. We are currently seeking a highly skilled and experienced Senior Cleaning Validation Specialist to join our team. In this role, you will be responsible for ensuring the cleanliness and compliance of our manufacturing facilities and equipment in accordance with industry standards and regulations. If you have a strong background in cleaning validation and a passion for maintaining the highest quality standards, we encourage you to apply for this exciting opportunity.
- Develop and maintain cleaning validation protocols and procedures for all manufacturing facilities and equipment, ensuring compliance with industry standards and regulations.
- Perform routine inspections and monitoring of manufacturing areas and equipment to ensure cleanliness and compliance with established protocols.
- Collaborate with cross-functional teams to identify and resolve any cleaning validation issues or non-compliance situations.
- Conduct risk assessments and implement corrective and preventive actions to address any potential risks to product quality or safety.
- Stay current with industry trends and regulations related to cleaning validation and make recommendations for process improvements as needed.
- Train and mentor junior staff on cleaning validation procedures and best practices.
- Work closely with Quality Assurance to ensure all cleaning validation activities are documented and maintained in accordance with company and regulatory standards.
- Participate in audits and inspections by regulatory agencies and assist with responding to any findings related to cleaning validation.
- Communicate effectively with internal stakeholders to provide updates on cleaning validation activities and any issues that may arise.
- Maintain accurate and up-to-date records of cleaning validation activities, including protocols, reports, and data analysis.
- Continuously evaluate and improve cleaning validation processes to ensure efficiency and effectiveness.
- Adhere to all safety protocols and procedures while performing cleaning validation activities.
- Represent Catalent in a professional manner at all times, promoting a positive image of the company and its commitment to quality.
- Collaborate with external vendors and suppliers as needed to ensure the availability of necessary cleaning validation materials and equipment.
- Serve as a subject matter expert on cleaning validation during internal and external discussions and meetings.
Extensive Knowledge Of Cleaning Validation Principles And Practices, Including Experience With Regulatory Requirements And Industry Standards Such As Fda And Eu Gmp Guidelines.
Minimum Of 5 Years Experience In A Cleaning Validation Role, Preferably In A Pharmaceutical Or Biotech Manufacturing Environment.
Strong Understanding Of Cgmps And Experience Working In A Highly Regulated Environment.
Proven Experience In Developing And Executing Cleaning Validation Protocols And Reports, Including Risk Assessments And Statistical Analysis.
Excellent Written And Verbal Communication Skills, With The Ability To Effectively Present Complex Technical Information To Cross-Functional Teams And Regulatory Agencies.
Process Improvement
Project Management
Analytical skills
GMP Knowledge
Quality Control
Risk assessment
Regulatory compliance
Problem-Solving
Documentation management
Validation Techniques
Cleaning Protocols
Communication
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Cleaning Validation Specialist in St. Petersburg, FL, USA is $62,000-$77,000 per year. This can vary depending on the specific company, years of experience, and other factors.
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Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians.
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