Associate Validation Engineer

Reporting to the Quality Assurance (QA) Manager or equivalent manager / supervisor, Associate 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

• 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.
• 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.
• 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. Performs other duties as required to support the overall plant operation and quality system.

Supervision Given

Does not supervise the work of others.

Education, Experience, & Skill Required

• Minimum BA or BS in a science related field (or international equivalent) and / or 4-6 years equivalent experience
• Two (2) to four (4) 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 a plus but not required.
• Experience in writing and executing validation protocols preferred.
• 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 minimum 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.

Special Requirements

• Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements
• Knowledge and experience working with the FDA and / or international requirements for medical devices is essential.
• Knowledge of regulatory affairs for 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 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).

Training Required

• Must complete all required training for a Quality Assurance Manager outlined in the training program.
Il y a 27 jours