Validation Engineer

The Validation Engineer has the primary responsibility to provide documented evidence through the developments and execution of protocols, the equipment, and processes used to manufacture regulated products.

Requirements:

• Requires an associate or bachelor's degree with a strong emphasis in a natural science or engineering.
• Requires the ability to read, analyze, and interpret business information, journals, technical procedures, or governmental regulations.
• Must have excellent communication skills (written and verbal) to write reports and findings and present to all levels of management in a clear and concise manner.
• Strong project management skills.
• Familiar with regulatory and GMP requirements for pharmaceutical manufacturing operations.
• PC proficiency to include Microsoft Office (Word, Excel, Access, PowerPoint) along with Google Suite and Microsoft Outlook, statistical analysis software, and contract management software.
• Proven ability to maintain confidentiality and discretion with information.

What you will do:

• Communicate technical knowledge with peers and colleagues in other departments.
• Develop and execute installation, operation, and performance qualification protocols and summary reports for processing equipment, utilities, computerized systems, and laboratory equipment.
• Develop and execute product validation protocols.
• Develop and execute cleaning validations.
• Perform training.
• Write Standard Operating Procedures (SOP's) / Work Instructions (Wis).
• Interface with customers.
• Must maintain good documentation practices.
• Communicate effectively with cross-functional groups to meet compliance requirements and release goals.
• Assist in the maintenance of the Validation Master Plan (VMP) and Cleaning Validation Master Plan (CVMP) schedules throughout the organization.