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Junior Validation Engineer
3 months ago
Reporting to the Quality Assurance (QA) Manager or equivalent supervisor, the Junior Validation Engineer will deliver essential information and data regarding all critical elements of each client's validation initiative. This information is utilized by both the facility and the client to guide routine processing decisions.
Key Responsibilities
Organizes and coordinates validation activities for clients at the facility. Develops validation protocols and final reports generated by the facility. Evaluates and endorses validation or testing protocols provided by clients or consultants, ensuring compliance with the facility's equipment capabilities and adherence to current regulatory standards. Oversees the execution of validation protocols and technically focused client projects, which encompass: Scheduling project runs, managing ancillary resources, conducting laboratory tests, and handling samples. Cycle programming and preparation of necessary process documentation and safety evaluations. Collection and analysis of microbiological samples, temperature, and humidity probe data. Ensuring proper handling, storage, and shipping of bioburden, LALs, biological indicators, or residual samples to designated laboratories. Ensures all validation calibration tasks are conducted according to established procedures and traceable to NIST standards. Provides assistance to Maintenance or Engineering teams during the IQ/OQ/PQ activities of new or existing equipment. Responsible for the annual re-commissioning of equipment (sterilization and laboratory). Updates validation status in relevant systems. May assist with corrective actions and validation process enhancements. Performs additional duties as necessary to support overall plant operations and quality systems.Supervision
Does not supervise others.Qualifications
A minimum of a BA or BS in a science-related discipline (or international equivalent) and/or 4-6 years of relevant experience. Two (2) to four (4) years of experience in the pharmaceutical, food, or medical device sectors with knowledge of GMP/GLP preferred but not mandatory. Direct experience in sterility assurance or product sterilization is advantageous but not required. Experience in drafting and executing validation protocols is preferred. Desired skills include customer service and project management experience. Familiarity with ISO 9000 standards is a plus. Excellent written and verbal communication skills are essential. Strong computer proficiency is required. Forklift operation experience is preferred; however, internal training will be provided. Must be capable of lifting a minimum of 50 lbs (23kg) and performing repetitive bending and lifting motions over time. Flexibility to work weekends and holidays as needed. Willingness to travel 10-20% to various locations as required.Special Requirements
Comprehensive understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements is essential. Knowledge and experience with FDA and/or international medical device regulations are crucial. Familiarity with regulatory affairs for FDA (or international equivalent) registered medical device or pharmaceutical manufacturers and direct experience with conducting or participating in FDA (or international equivalent) or supplier audits is necessary. Experience in document control to meet all ISO 9000 and FDA (or international equivalent) Quality System requirements is required. Must be medically cleared for respirator use (EO). Ability to tolerate exposure to high temperatures and humidity [up to 130F (55C) and 65% RH for 20 minutes] (EO).Required Training
Completion of all mandatory training for a "Quality Assurance Manager" as outlined in the training program.