Key Responsibilities
* Coordinate installation and qualification activities for equipment and systems
* Prepare and review validation documentation such as URS, DQ, risk assessments, FAT, SAT, and validation protocols including IQ, OQ, and PQ
* Execute qualification protocols for equipment, systems, and utilities and ensure proper documentation of results according to cGMP standards
* Generate reports summarizing completed validation and qualification activities
* Contribute to the validation lifecycle including gap analysis, risk evaluation, and technical documentation
* Identify opportunities to improve efficiency within validation processes and apply lessons learned across projects
* Ensure validation activities remain aligned with current regulatory expectations and industry best practices
* Support quality system processes including document management, change control, deviations, and CAPA activities
* Develop and update procedures related to engineering and validation activities
* Collaborate with engineering teams to support validation strategies, requalification programs, and maintenance planning
* Perform additional project-related tasks as required