Job Summary
This role involves performing testing to ensure cGMP compliance in a manufacturing facility. Responsibilities include assessing the microbiological quality of products, manufacturing equipment, process areas, and facility utilities.
Key Responsibilities
* Enter laboratory clean-rooms to collect and log samples for microbial analysis.
* Perform bioburden and endotoxin sample analysis in line with standard operating procedures (SOPs).
* Conduct sample analysis for microbial identification.
* Implement environmental monitoring, including surface, settling, and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
* Verify acceptance testing of commercially prepared microbiological culture media.
* Autoclave microbiological media and laboratory waste as needed.
* Maintain all work in compliance with regulatory standards, company policies, and SOPs.
* Complete test records on time and review peer data from other analysts for accuracy and completeness.
* Support the design and setup of the QC microbiology laboratory and select, implement, and calibrate laboratory instruments.
* Participate in microbiological validations for drug substances, in-process controls, buffers, and clean utilities qualification programs.
* Assist manufacturing personnel in identifying microbiological root causes and provide technical advice as needed.
* Transfer methodologies from other test facilities.
* Manage laboratory reagents, media, and supplies.
* Investigate laboratory issues and generate reports in response to invalid assays, deviations, OOS/OOT.
* Pursue and complete CAPAs and change controls in adherence with site procedures.
* Communicate analytical data reports clearly and concisely to management.
* Identify and implement lab process improvements and lean initiatives.
About You
* You must have a consistent record to work independently or as part of a team.
* You possess strong trouble-shooting and problem-solving skills.
* You have strong attention to detail & excellent written and oral communication skills.
Requirements
* A BS/BA or equivalent experience in Microbiology or related field is required.
* Two+ years of validated experience or an equivalent combination of education and experience are also required.
Work Environment
This is a shift-based role (12/7 - extended days).
Culture
We have an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
EEO Statement
Regeneron is an equal opportunity employer and will consider all qualified applicants 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.