JOB SUMMARY:
Reporting to the Quality Assurance (QA) Manager, the Validation Coordinator acting as the facility technical representative is responsible for ensuring the requirements for ISO and QSRs are met and maintained for the facility and its customers. The Validation Coordinator provides management with information and data on all key aspects of each customer’s validation project, which is used by both the plant and the customer to determine the course of routine processing. Must effectively interface with Sales, Operations, Corporate EO Technology, Engineering and other Sterigenics’ facilities, as well as customers and regulatory personnel.
DUTIES AND RESPONSIBILITIES:
- Plans, organizes and coordinates customer validation activities at the facility
- Writes validation protocols and final reports supplied by the facility
- Reviews and approves customer or consultant supplied validation or test protocols for excitability within the limitation of the facility’s equipment and Sterigenics operating procedures and compliance with current regulatory standards
- Responsible for the execution of validation protocols and technically driven customer projects, which include but are not limited to the following:
- Scheduling the project runs, ancillary resources, lab testing and sample handling
- Cycle programming and preparation of necessary process documents and safety assessments
- Microbiological samples
- Data collection and analysis
- Assuring proper handling, storage and shipping of bioburden, LAL biological indicators engineering, or residual samples to the appropriate laboratory
- Assures that all validation calibration activities are performed according to Sterigenics QSR and traceable to NIST
- Provides support to Maintenance or Engineering in the performance of IQ/OQ/PQ activities of new or existing facility equipment
- Provides on-going training to the plant on validation issues
- Maintains the quality and integrity of information required for validation records
- Liaison for all plant and customer activities responding to customers’ inquiries whether directly or through Quality Assurance, Customer Service Unit or Sales, to ensure prompt and accurate communication related to technical and validation issues
- Performs other duties as required to support the overall plant operation and quality system
Job Requirements:
EDUCATION, EXPERIENCE & SKILL REQUIRED:
- Minimum BA or BS in a science related field
- Two (2) to three (3) years’ experience in the pharmaceutical, food or medical device industry
- Direct experience in sterility assurance or products sterilization a plus
- Must have experience in writing and executing validation protocols
- ISO 9000 experience a plus
- Excellent written and verbal communication skills
- Strong computer skills
SPECIAL REQUIREMENTS:
- Must possess a thorough understanding of US FDA Quality Systems Regulations and ISO 9000 regulations
- Understanding of AAMI, EN and ISO guidelines for EO sterilization of medical devices is desirable
- Knowledge and experience working with the US and International requirements for medical devices is essential
- Knowledge of regulatory affairs for a FDA registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA or supplier audits
- Experience with a company using EO sterilization of products is desirable
- Experience in document control to satisfy all ISO 9000 and FDA Quality System requirements
- Must be medically approved for respirator use (EO)
- Must be able to tolerate exposure to high temperatures and high humidity (120F and 60% RH for 20 minutes) (EO)
TRAINING REQUIRED: Must complete all required training for a “Validation Coordinator” outlined in the training manual
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.