Senior Associate, Research Operations - Validation
By Sarepta Therapeutics At Columbus, OH, United States
Managing equipment induction activities including selection, procurement, qualification, and CSV
Reviewing and approving vendor-supplied qualification documentation
Maintaining current and accurate inventories of all equipment and software versions, including qualification status
Minimum of 2 years of experience in managing equipment commissioning, including CSV
Experience in assay method validations
Minimum of 5 years of experience in a quality role, preferably in a GLP environment

Are you looking for an exciting new challenge in Senior Validation Engineering? We are looking for a highly motivated individual to join our team and help us ensure the quality of our products. You will be responsible for developing and executing validation plans and protocols, as well as providing technical support and guidance to the validation team. If you have experience in validation engineering and are looking for an opportunity to make a real impact, this could be the perfect job for you!

A Senior Validation Engineer is responsible for ensuring that products meet the required quality standards and regulatory requirements. They are responsible for developing and executing validation plans, protocols, and reports.

What is Senior Validation Engineer Skills Required?

• Knowledge of validation principles and practices
• Knowledge of FDA regulations and Good Manufacturing Practices (GMP)
• Ability to interpret and analyze data
• Strong problem-solving and troubleshooting skills
• Excellent communication and interpersonal skills
• Ability to work independently and in a team environment

What is Senior Validation Engineer Qualifications?

• Bachelor’s degree in engineering, science, or related field
• 5+ years of experience in validation engineering
• Experience in the pharmaceutical or medical device industry

What is Senior Validation Engineer Knowledge?

• Knowledge of validation principles and practices
• Knowledge of FDA regulations and Good Manufacturing Practices (GMP)
• Knowledge of Quality Management Systems (QMS)
• Knowledge of statistical analysis and data interpretation

What is Senior Validation Engineer Experience?

• 5+ years of experience in validation engineering
• Experience in the pharmaceutical or medical device industry
• Experience in developing and executing validation plans, protocols, and reports

What is Senior Validation Engineer Responsibilities?

• Develop and execute validation plans, protocols, and reports
• Ensure that products meet the required quality standards and