Microbiology Project Manager
1 year contract
- Manages the day-to-day activities of the Microbiology Technicians.
- Develops and oversees policies and procedures related to cleanrooms, sterilization, and medical device biocompatibility to insure that they are in compliance with corporate, QSR, ISO, and other regulatory compliance requirements.
- Responsible for developing and implementing sterilization procedures and policies and performing validations of the sterilization processes.
- Coordinates and conducts medical device risk assessments for biocompatibility and determines appropriate testing.
- Oversees the validation schedules for gamma and ethylene oxide sterilization and maintains files and records.
- Administers training for the facility on sterilization and cleanroom control.
- Interfaces with sterilization contractors to review processes, determine validation requirements, and coordinates the validation.
- Interfaces with Product Development Engineers to determine appropriate sterilization methods for new products.
- Works with suppliers, management, Engineers, and Manufacturing Associates in the resolution of quality problems associated with sterilization and cleanroom control.
- Performs internal and external audits associated with microbiology activities.
- The Microbiology Project Manager will be interacting on a daily basis with Quality and Manufacturing Engineers and Managers.
- The Microbiology Project Manager has the lead responsibility for conveying microbiological policies and procedures to other departments and to regulatory bodies, such as FDA and notified bodies.
- The Microbiology Project Manager will be responsible for carrying out the corporate policies within ASD. It will be necessary to make presentations to management when changes are needed to the program or in association with key projects.
- The Microbiology Project Manager will have the training and knowledge necessary to guide the direction of the microbiology program.
- The Microbiology Project Manager will work within the validation policies established by *** Inc. Key to these policies is an understanding of the national and international organizations that define the quality requirements for a validation.
- The Microbiology Project Manager will report changes in these requirements and make changes to the microbiological policies where needed.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.
- Proficiency in Windows and Microsoft Office applications (Word, Excel, Outlook)
- Proficiency in Statistical Software
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The Validation Project Manager may spend approximately 25% of the time walking or standing.
- Thirty percent of the time may be spent at a computer keyboard.
- The Validation Project Manager must be able to speak and hear well enough to communicate effectively.
- Since the position involves validation of manufacturing, the Validation Project Manager must be able to observe manufacturing operations and perform and have the ability to perform basic laboratory tests as needed.
- In performing the duties on the manufacturing floor, it may be necessary to lift up to 50 pounds.
- Observation of manufacturing operations and testing requires that the Validation Project Manager have excellent or corrected vision.