This role is responsible for supporting the validation effort to ensure that equipment, facilities, utilities and computer systems utilized in the manufacture of product, are validated for intended use
Job Summary
This role is responsible for supporting the validation effort to ensure that equipment, facilities, utilities and computer systems utilized in the manufacture of product, are validated for intended use.
Responsible for process related activities including the development of validation strategies, the estimation of validation timelines and resource requirements, the generation and approval of the project validation plans, the development of robust and efficient validation test protocols and reports, for new and existing facilities, utilities and equipment.
We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package.
Matching Summary
This role is responsible for supporting the validation effort to ensure that equipment, facilities, utilities and computer systems utilized in the manufacture of product, are validated for intended use.
Skills & Requirements
Must-have
Validation strategies development
Validation test protocols and reports
Environmental monitoring studies
Data integrity documentation
Computerized systems administration
Cross-functional team collaboration
Deficiency and deviation resolution
Nice-to-have
Adaptable to dynamic project schedules
Independent thought and creativity
Judgment within defined policies
Alignment and communication of issues
Support regulatory audits
Key Requirements
Bachelor’s degree in engineering or science
cGxP validation experience
Investigations and root cause analysis experience
Excellent technical writing skills
Excellent verbal communication skills
Manage complex validation projects
Advanced Microsoft Word, Outlook, and Excel skills