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The Birmingham office of Organogenesis is seeking a qualified and responsible Validation Engineer I/II. In this position, the Validation Engineer will be designated to support validations for a CGMP and CGTP facility. The engineer will be responsible for assisting with executing Installation, Operation, Performance Qualification, Requalification and Revalidation protocols for final product transport containers, final product storage equipment and other instrumentation needed for product monitoring and inspections using established validation templates, standards and procedures. The Validation Engineer will write and execute protocols for assigned validations. The Validation Engineer will also assist in process and cleaning validations as needed. This position will also support the implementation of appropriate validation SOPs; as applicable to the job responsibilities. The Validation Engineer reports to the Quality Director.
Key Job Responsibilities:
Prepares protocols and reports for validation, requalification and revalidation work.
Assists with coordination and execution of validation studies for equipment including autoclaves, glass washers, depyrogenation ovens, utility systems (purified water, WFI water, gas systems, clean steam), incubators, clean rooms, freezers, refrigerators and transport containers.
Performs testing using standard concepts, practices and procedures of the CGMP process.
Prepares, reviews and summarizes equipment history files to assess the validated state of equipment.
Assist in process and cleaning validations as required.
Supports other OI Validation Engineers in the execution of validation protocols.
Participate in the review of Standard Operating Procedures (SOPs) for system projects.
Associates degree required. Bachelor degree preferred.
2+ years of Validation experience in Pharmaceutical/Medical Device industry required.
Familiarity with aseptic processing and clean room operations preferred.
Competency with Kaye Validator programming or remote data loggers and calibration of thermocouples, validation of test equipment, and technical writing skills are preferred.
Strong working knowledge of Microsoft Suite required.
Experience in temperature mapping preferred.
Able to work independently.
Strong organizational skills.
Excellent verbal and written communication.
Experience with regulatory requirements required.
Familiarity with GMP documentation, data recording, and record keeping. Previous experience in GMP/Clean Room operations preferred.
Frequently is required to stand and talk or hear; and walk or sit.
Regularly required to use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms.
Frequently around loud noises.
Frequently works near moving mechanical parts.
Frequently exposed to hot, cold, wet or humid conditions, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock.
Organogenesis Surgical and Sports Medicine - Birmingham, AL 35216 US (Primary)
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