Validation Specialist - VS

Position Title: Validation Specialist
Location: Millsboro, DE
Duration: 12 months

Education Required:

• Bachelor’s degree in Engineering, Life Sciences, or related field with 2 years of experience
• High School or GED with 4 relevant experience will also be considered.

Required Experience and Skills:

• Strong background in equipment calibration documentation and validation lifecycle management.
• Experience in supporting validation activities such as qualification, documentation, and data analysis.
• Knowledge of documentation accuracy and comprehension in compliance with regulatory standards.
• Demonstrated ability to author technical documentation that supports validation and qualification efforts.
• Strong attention to detail, especially in documentation accuracy.
• Ability to work independently and as part of a team, managing multiple tasks simultaneously.
• Solid communication skills, both written and verbal, for effective documentation and collaboration across teams.
• Prior experience in regulated industries (pharmaceutical, medical device, or similar fields) is preferred.

Preferred Experience and Skills:

• Experience with documentation management systems for calibration and validation processes.
• Familiarity with cGMP (current Good Manufacturing Practices) and regulatory standards is a plus.
• Experience in data analysis, reporting, and visualizations as part of validation activities.
• Previous exposure to validation protocols and reports (IQ/OQ/PQ).
• Experience with equipment calibration or qualification and associated documentation.
• Ability to collaborate with cross-functional teams (e.g., Quality, Operations, Engineering) in a regulated setting.

Responsibilities:

• Provide validation support for equipment calibration documentation and validation activities throughout the product lifecycle.
• Assist in documentation accuracy for validation studies, ensuring compliance with corporate and industry standards.
• Review and ensure accuracy of validation documentation, such as protocols and reports, to maintain compliance.
• Collaborate with cross-functional teams to ensure validation requirements are met for equipment, processes, and systems.
• Develop and implement corrective actions for unplanned events or deviations in the validation processes.
• Support change control documentation for any updates or modifications to validated processes or equipment.
• Ensure that all validation activities align with the company’s regulatory standards and best practices.
• Assist in the development and management of project plans for validation activities, ensuring timely execution.
• Provide expertise in troubleshooting issues and recommending solutions related to validation and equipment calibration.