
Validation Specialist
Are you passionate about ensuring the safety and efficacy of pharmaceutical products? Do you have a keen eye for detail and a strong understanding of regulatory requirements? If so, we have an exciting opportunity for you to join our team as a Validation Specialist at Catalent.As a global leader in drug development and delivery solutions, Catalent is committed to delivering high-quality, reliable products to our clients. As a Validation Specialist, you will play a critical role in this mission by designing and executing validation strategies for our manufacturing processes and equipment.To excel in this role, you will need to have a Bachelor's degree in a scientific or engineering field, along with at least 2 years of experience in pharmaceutical validation. You should also have a thorough understanding of GMP regulations and be able to work independently to meet project deadlines.If you are a detail-oriented and driven individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity and become a part of our dynamic team at Catalent.
- Develop and implement validation strategies for manufacturing processes and equipment to ensure compliance with regulatory requirements.
- Design and execute validation protocols for new and existing products, processes, and equipment.
- Perform risk assessments and identify potential areas for improvement in validation processes.
- Collaborate with cross-functional teams to ensure timely completion of validation activities and project deadlines.
- Maintain and update validation documentation, including protocols, reports, and standard operating procedures.
- Conduct investigations and troubleshoot validation issues to identify root causes and implement corrective actions.
- Stay current with industry trends and regulatory changes related to validation requirements and ensure compliance with all applicable regulations.
- Provide support and guidance to other team members on validation activities and best practices.
- Participate in internal and external audits and inspections, providing necessary documentation and addressing any findings or observations.
- Continuously evaluate and improve validation processes to enhance efficiency and effectiveness.
- Communicate clearly and effectively with stakeholders, including management, clients, and regulatory bodies.
- Maintain a high level of attention to detail and accuracy in all validation activities.
- Uphold company values and standards of quality and safety in all validation activities.
- Act as a subject matter expert on validation requirements and procedures, providing training and guidance to colleagues as needed.
- Maintain confidentiality and integrity of sensitive information related to validation activities.
Bachelor's Degree In A Scientific Field Such As Chemistry, Biology, Or Pharmacy.
Minimum Of 3-5 Years Of Experience In A Pharmaceutical Or Biotech Company, With A Focus On Validation Activities.
Strong Understanding Of Fda Regulations, Cgmp Guidelines, And Industry Best Practices Related To Validation.
Experience In Performing And Overseeing Validation Activities For Various Processes, Including Equipment, Utilities, And Computer Systems.
Excellent Communication And Organizational Skills, With The Ability To Work Independently And As Part Of A Cross-Functional Team.
Troubleshooting
Data Analysis
statistical analysis
Quality Control
Root Cause Analysis
Process validation
Risk assessment
Documentation management
GMP compliance
Protocol Development
Equipment Qualification
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
Decision-making
According to JobzMall, the average salary range for a Validation Specialist in Winchester, KY 40391, USA is $55,000-$75,000 per year. Salaries may vary depending on the specific job responsibilities, experience, and education level of the individual.
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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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