Requirements Analyst IV
1 yr renewable contract
*Must Have on Resume*
1. Ethylene Oxide sterilization and validation experience
2. Microbiology experience
3. Environmental monitoring experience
Lead efforts to develop sterilization cycle and methodologies for new product development. This position will also be accountable in managing Andover cleanroom/s.
? Lead sterilization cycle definition, development, and validation, ensure that all corresponding activities were executed and sufficiently resourced.
? Work with cross functional team engage in the sterilization activities and be the subject matter expert pertaining to sterilization.
? Manage and coordinate routine sterilization including test related to release of the lots. Tests include Bioburden, Product sterility test, Endotoxin, EO Residual testing and BI sterility testing.
? Creation and maintenance of standard operating procedure and work instruction related to sterilization, Environmental monitoring, and Microbiology.
? Manage and maintain the Andover Environmental Monitoring program including coordinating maintenance activities related to cleanroom and critical utilities.
? Cleanroom training and qualification of embecta associates.
? Coordinate and schedule the environmental monitoring and cleaning of the Andover cleanroom.
? Responsible for the investigation and resolution of EM excursions.
? Create/prepare Environmental Monitoring monthly metrics.
EXPERIENCE & EDUCATION:
? BS degree in engineering, science, or technical discipline. MS preferred.
? Minimum of 3-5 years relevant technical experience in EtO sterilization.
? Microbiology and environmental monitoring experience is a must
? Medical Device industry experience preferred.
KNOWLEDGE, SKILLS AND ABILITIES:
? Excellent verbal and written communication skills.
? Extensive knowledge in ISO 10993, ISO 11135, ISO 14161, ISO 11737, ISO 10993, ISO 14698 and ISO 14644.
? Knowledge and experience in product development emphasis cycle development, validation and maintenance.
? Knowledge and experience environmental monitoring and microbiology.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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