POSITION SUMMARY

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

RESPONSIBILITIES

• Lead validation projects to include planning, scheduling execution and reports.
• 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 reports for the executed protocols with support and guidance from senior level staff.
• Contribute to the generation and review 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 reporting and communication of projects to project manager, stakeholders and department manager.

QUALIFICATIONS

• Bachelor’s degree in science/engineering or related field with 3-5 years’ work experience.
• 3-5 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.
• Skills/Abilities
• 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.
• 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.
• Ability to read/interpret P&ID drawings