Supports improvement to and management of the site validation program by completing validation assessments, authoring test protocol and reports, facilitating resolution of validation deviations, monitoring validation-relevant data and maintaining validation administration documents.
Essential Duties & Responsibilities
Assesses assets and processes for qualification, validation, re-validation or verification needs.
Coordinates and manages the qualification and validation strategies for applicable facilities, utilities, equipment, test methods, computerized systems and processes.
Develops validation and qualification protocols and tracks execution of protocols in support of project timelines.
Enters administrative data in Validation Checklist execution copies in compliance with current site documentation requirements.
Executes protocols where acceptable.
Reviews and analyzes protocol data to determine if requirements are met. Facilitates resolution of validation deviations encountered during protocol execution.
Prepares and submits protocol reports and validation reports for internal review and approval.
Maintains the hard copy and electronic versions of the Validation Checklist archive.
Evaluates, makes recommendations and implements changes to the validation and qualification program as part of continual improvement or remediation activities.
Monitors data for adverse trends regarding the validated state of a system or process.
Maintains master listing of systems and processes and their validated status.
Provides input to the validation and qualification system level documents including master validation plans, policies and procedures.
Support all company safety and quality programs and initiatives.
Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Education & Experience Requirements
BS in Engineering, technical discipline or scientific field required.
Intermediate proficiency with Microsoft Word, Excel, PowerPoint and Outlook. Proficiency with Microsoft Access is a plus.
4 plus years of experience in validation / qualification in healthcare or other regulated field. Demonstrable experience in qualification of equipment, facilities and utilities and validation of processes, computerized systems and test methods preferred.
Working knowledge of ISO13485 and 9001 or equivalent.
Knowledge of 21 CFR 820, or 21 CFR 210, 211 and Part 11 is a plus.
Jabil is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other status protected by law.