PROKIDNEY LLC Hiring for Validation Engineer at Winston-Salem, NC Full Time

The Validation Engineer will support equipment, process, and cleaning validation activities. This role will help develop, author, review and execute all validation protocols and s with guidance from senior level staff. The Validation Engineer will help coordinate all validation activities and projects with departmental manager.

The Validation Engineer will be responsible for supporting the Validation/Qualification program by:

• Lead validation projects to include planning, scheduling execution and s.
• Develop and Author Validation/Qualification protocols at the manufacturing facility for cleaning processes, equipment, utility, and facilities.
• Execute validation/qualification protocols for cleaning processes, equipment, utility, and facilities.
• Prepare validation/qualification summary s for the executed protocols with support and guidance from senior level staff.
• Contribute to the generation and review of required documentation (Standard Operating Procedures, protocols, change controls and change requests) to support validation activities and program.
• Applies standard techniques and procedures to carry out a series of scientific and/or engineering tasks.
• Provide adequate ing and communication of projects to project manager, stakeholders and department manager.
• Experience interacting with various groups at facility to develop plan/validation strategy for projects.
• Experience interacting with project engineers to obtain the necessary information to fulfill validation documents.

Requirements:

Education and Experience:

• Bachelors Degree in Science/Engineering or related field with 3+ years of related work experience required
• 3+ years of related validation experience in a cGMP environment.
• Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.
• Minimum of 3 years of prior experience developing, authoring and execution of validation protocols in a manufacturing environment.
• Detail orientated and ability to work in a fast-paced environment with the ability to handle multitude of projects with overlapping schedules.
• Knowledge and understanding of validation lifecycle.
• Strong Mechanical aptitude and strong technical writing skills.
• Experience with equipment qualification methodologies.
• Ability to read/interpret P&ID drawings