Validation Engineer III

Integrated Resources Inc.; La Verne (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading company in pharmaceutical validation is seeking a Validation Specialist to manage and execute validation projects for manufacturing systems. The role requires developing validation master plans, conducting reviews, and ensuring compliance during inspections. Candidates should have a strong background in project management and quality assurance within a regulated environment.

Qualifications

• Experience in performing validation for equipment and processes.
• Ability to develop validation protocols and master plans.

Responsibilities

• Perform validation of equipment and processes.
• Develop validation schedules and protocols for complex systems.
• Coordinate validation activities and review generated documentation.

Skills

Project Management

Quality Assurance

Education

Bachelor's Degree in Science or Engineering

Job description

• Responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision, preparing protocols independently, analyzing test results, and preparing technical reports.
• Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
• Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget.
• Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work.
• Reviews protocols, reports and data tables generated by peers and contract personnel.
• Represents the department on cross-functional project teams.
• As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections.
• **Possible weekend / Holiday work may be required due to department workload. Schedule must be flexible to accommodate off-shift work.**

Additional Information

All your information will be kept confidential according to EEO guidelines.