Senior Microbiology Supervisor

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people experience life’s beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com

• Oversee and manage daily operations of the microbiology laboratory, focusing on environmental monitoring, bioburden, endotoxin, sterility, microbial identification testing.

• Ensure laboratory testing activities are executed efficiently, accurately and in alignment with production schedules and business priorities

• Ensure compliance with ISO 17025, ISO 13485, USP/EP microbiological methods, and regulatory requirements.

• Maintain laboratory systems aligned with data integrity and quality standards.

• Ensure accurate and timely documentation of all microbiological activities and test results.

• Recruit, train, mentor, and evaluate microbiology laboratory staff.

• Ensure personnel are qualified in microbiological techniques, aseptic practices, and safety procedures.

• Foster a culture of accountability, continuous improvement, and scientific excellence.

• Ensure ongoing training and competency assessments for laboratory personnel.

• Coordinate daily workload allocation, scheduling, and prioritization to meet operational needs and turnaround time (TAT) targets

• Oversee inventory of microbiological media, reagents, and consumables to ensure uninterrupted operationsz.

• Ensure proper storage, preparation, and handling of microbiological materials.

• Drive efficiency improvements in cycle times, testing reliability, and laboratory throughput.

• Represent the laboratory as a Microbiology SME during internal/ external audits and inspections. 

• Oversee microbiological method validation, verification, and transfer activities (e.g., sterility, endotoxin, bioburden).

• Ensure proper qualification and validation of microbiological equipment (e.g., incubators, autoclaves, endotoxin readers).

• Provide technical expertise in aseptic techniques, contamination control, and laboratory investigations.

• Ensure application of microbiological best practices and scientific rigor in testing and troubleshooting

• Lead and support investigations related to microbiological deviations, OOS/OOT results, contamination events, and environmental excursions.

• Drive CAPA, NCMR, and root cause analysis (e.g., DMAIC) for microbiological issues.

• Monitor laboratory trends (e.g., environmental monitoring, sterility failures) and implement preventive actions.

• Ensure adherence to validation master plans related to microbiological testing and controls.

• Partner with Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to support product release and investigations.

• Provide microbiology expertise in new product introductions, risk assessments, and process changes.

• Fulfill role of microbiology laboratory regency. 

• Reviewer and approval of specified Standard Operating Procedures.

• Other tasks required by the business.

  Travel: 

• Less than 10% travel requirement

• Strong knowledge of microbiological testing methods (sterility, endotoxin, bioburden, EM, microbial ID).
• Operative understanding of applicable regulatory standards (ISO 17025, ISO 13485, USP <71>, <85>, <61>/<62>).
• Strong leadership, problem-solving, and organizational skills.
• Knowledge of Lean, Six Sigma, CAPA, and root cause methodologies preferred. 
• Capability to work independently and manage multiple tasks with minimal supervision.
• Proficient in Microsoft Office.

• English level 85+ for reading, writing technical reports, speaking.

  Work Environment:

• Prolonged sitting in front of a computer

  Experience:

• A minimum of 5 years of experience in a microbiology laboratory, including supervisory experience.
• Regulated industry (such as ISO17025, EU GMP, FDA) experience is required, preferably medical devices or pharmaceutical.
• Experience with microbiological method validation and equipment qualification, including analytical method transfer is required. 

• Experience with international compendiums such as USP, ACS, Ph.Eur, ASTM is required.

• Experience in aseptic processing environments and contamination control strategies preferred.

  Education:

• Licenciatura in Microbiology. Incorporated to Microbiology Professional Association.
• Specialization or Master´s in analytical methods or quality related is highly desirable

 

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.  If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com