Temp - QC Microbiology Scientist (Temp)
Location: Limerick, County Limerick, Ireland. Company: BioSpace.
Responsibilities
Within this role you will perform testing method development, optimization and validation for the QC Microbiology group. Provide technical support and guidance for release testing, in-process testing, and microbiological investigations. Provide technical expertise regarding Environmental Monitoring.
* Validating methods and equipment related to sterility, bioburden, endotoxin testing and microbial identifications.
* Writing technical documentation, including position papers, validation reports and microbiological investigations.
* Culturing organisms, conducting research and characterizing them for use in investigations and cleaning development.
* Reviewing new test procedures and assays for accuracy and compliance.
* Evaluating and acquiring new methodologies, techniques and equipment as needed.
* Overseeing contract laboratory testing to ensure quality and compliance.
* Setting product specifications and alert/action levels for microbiological standards.
* Leading technical troubleshooting and problem investigations.
* Reviewing assay, process and equipment validation reports, as well as other technical documents for correctness and regulatory compliance.
* Coaching junior team members on good microbiology lab practices and modern aseptic techniques.
* Leading audits of vendors, external laboratories, business partners and contracted manufacturers as needed.
* Supporting and participating in regulatory inspections to ensure compliance.
* Possessing a strong background in pharmaceutical microbiology, GMP working experience in QC labs and aseptic techniques.
* Demonstrating investigational skills and working knowledge of microbiology assay development and validation.
* Requiring advanced knowledge of aseptic manufacturing operations.
Qualifications
* You have a BS/BA or equivalent experience in Microbiology or a related field and 2+ years of validated experience, or an equivalent combination of education and experience.
* You have a proven record of working independently or as part of a team.
* You possess strong trouble‑shooting and problem‑solving skills.
* You have strong attention to detail and excellent written and oral communication skills.
* Advanced knowledge of aseptic manufacturing operations.
Equal Opportunity Statement
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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