QA Microbiology Specialist

Responsible for implementing microbiologically based initiatives as part of the QA Microbiology team at IOPS Raheen. Aspects of investigation activities, training, project implementation, and data collection and analysis will be utilized. Knowledge of Biopharmaceuticals and cell culture manufacturing required.

Essential Duties and Responsibilities include but are not limited to the following:

Foster working relationships between multiple Regeneron departmental representatives.

Maintain current knowledge in microbiological practices and methods as they relate to the biopharmaceutical industry and Regeneron expectations for microbial control/ mitigatioan.

Observe manufacturing operations on the floor to provide constructive feedback for strengthening microbial controls and aseptic practices;

Support roll out of relevant training and/or provide coaching to IOPS personnel related to Microbiology and Microbiological controls including: Standardize microbial training activities through coordination with all sites of Regeneron Industrial Operations and Product Supply (IOPS). Participate in multidisciplinary project teams to coordinate and establish training goals and implement training initiatives related to microbial controls.

Aid investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plans determination, product impact, and remediation plans

Review and provide input on SOPs, validation protocol/reports, Environmental Monitoring quarterly reports and related documentation in support of biopharmaceutical manufacturing and testing;

Support the activities of other departments across IOPS when relevant to Microbiological controls;

Support other duties assigned by QA Microbiology management

Occasional domestic and some foreign travel required.

Knowledge, Skills and Abilities:

Excellent written and oral communication skills.

Ability to foster working relationships between Regeneron departmental representatives at all management levels.

Knowledge and understanding of microbial contamination controls in a biopharmaceutical manufacturing facility.

Knowledge of current industry microbial control practices required.

Education and Experience:

Requires Bachelors in Microbiology or Life Science field and 3-5+ years proven

experience in the pharmaceutical/biotechnology, or related, industry.

Experience in creating and delivering training to all levels of personnel.

Relevant experience may be considered in lieu of the educational requirement

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