Validation Engineer - Kentucky

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry.

Requirements

• Develop, execute, and oversee cleaning validation strategies and protocols for solid dose manufacturing equipment and processes.
• Collaborate with cross-functional teams to establish cleaning validation requirements, ensuring alignment with regulatory standards and industry best practices.
• Perform risk assessments and gap analyses related to cleaning processes, proposing and implementing corrective actions as needed.
• Generate and maintain cleaning validation documentation, including protocols, reports, and standard operating procedures (SOPs).
• Conduct equipment qualification activities in coordination with the validation team.
• Coordinate and execute cleaning validation studies, ensuring thoroughness and accuracy in data collection and analysis.
• Investigate and resolve deviations related to cleaning processes, collaborating with Quality Assurance and Manufacturing teams.
• Stay abreast of industry trends, regulatory requirements, and technological advancements in cleaning validation, providing recommendations for continuous improvement.
• Participate in regulatory inspections and audits, providing support and documentation as required.

Benefits

• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives