- 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 execution within the limitation of the facility's equipment and Sterigenics operating procedures and compliance with current regulatory standards
- 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
- Ensure validation activities are carried out according to the agreed time-schedule and communicate follow up to relevant persons (validation manager, EAS, sales, etc)
- Forecast validation revenue based on projects timelines and invoice all validation projects
- Organize work of validation technician(s) for load preparation in collaboration with the validation team leader.
- Responsible subject matter expert for audits in regard to validation activities (interaction with customer/internal/regulatory body auditors)
- Will be expected to be the lead person within the facility's validation department.
- 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 of temperature and humidity probe data
- Assuring proper handling, storage and shipping of bioburden, LALs, biological indicators, or residual samples to the appropriate laboratory
- Assures that all validation calibration activities are performed according to Sterigenics procedures 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
- Responsible for annual equipment re-commissioning (sterilization and laboratory).
- Update validation status in the relevant systems.
- May be required to assist with corrective action and validation process improvement activities.
- Inform facility stakeholders regarding validation related deficiencies.
- Performs other duties as required to support the overall plant operation and quality system
- May supervise/guide the work of others within the validation department
- Minimum BA or BS in a science related field (or international equivalent) and 4+ years experience.
- Four (4) to six (6) years' experience in the pharmaceutical, food or medical device industry with GMP/GLP knowledge a plus but not required.
- Direct experience in sterility assurance or products sterilization required.
- Must have experience in writing and executing validation protocols.
- Customer service and project management experience desired.
- ISO 9000 experience a plus.
•Excellent written and verbal communication skills. - Strong computer skills.
•Forklift driving experience preferred, however internal training will be given. - Must be able to lift a maximum of 50 lbs. (23kg) and perform repetitive bending and lifting motions over a period of time.
- Must be able to work a flexible schedule including weekends, holidays (if necessary).
- Must be able to travel 10-20% to various locations as needed.
- Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements
- Understanding of AAMI, EN and ISO guidelines for EO sterilization of medical devices is desirable
- Knowledge and experience working with the FDA and/or international requirements for medical devices is essential
- Knowledge of regulatory affairs for a FDA (or international equivalent) registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA (or international equivalent) 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 (or international equivalent) Quality System requirements
- Must be medically approved for respirator use (EO)
- Must be able to tolerate exposure to high temperatures and high humidity [up to 130F (55C) and 65% RH for 20 minutes] (EO)
- Must complete all required training for validation internal certification
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Description
Job DescriptionReporting to the Quality Assurance (QA) Manager or equivalent manager/supervisor, the Validation Engineer acts as the facility technical representative responsible for ensuring the requirements for ISO are met and maintained for the facility and its customers. Validation Engineer will provide 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, Laboratory (if any), EHS, Quality, Engineering and other Sterigenics' facilities, as well as customers and regulatory personnel.
Duties and Responsibilities
VEVRAA Federal Contractor
