Responsable, Microbiologie

JOB DESCRIPTION ENGLISH Manager, Microbiology - Environmental Monitoring Jubilant HollisterStier , a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting a Manager, Microbiology - Environmental Monitoring to join our team What We Offer: A culture that values growth and professional development opportunities, a highly competitive base salary, comprehensive health, dental, and disability insurance programs, a group retirement plan, and wellness programs. Jubilant HollisterStier is a rapidly growing company with offices in Kirkland, Quebec, and Spokane, Washington. As a fully integrated contract manufacturing organization, Jubilant HollisterStier is equipped to manufacture sterile injectable formulations, as well as solid and semi-solid dosage forms. Our four facilities in North America and India provide specialized manufacturing services for the pharmaceutical and biopharmaceutical sectors. Jubilant HollisterStier is proudly part of the Jubilant Pharma family. For more information, visit . We continue—with the utmost care for the environment and society—to create value for our clients and stakeholders by offering innovative products and cost-effective solutions through growth, profitability, and prudent resource investment. If you’re ready for a rewarding challenge, we invite you to take the first step and apply today Jubilant Pharma Holdings Inc. and all our subsidiaries are proud of the diversity of our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We foster an inclusive environment where our employees can thrive and where differences are welcomed. By embracing our differences, we create products that benefit our patients, clients, and human health overall. Purpose of the Job: The Manager, Environmental Monitoring and Microbiology is responsible for overseeing the environmental monitoring (EM) and microbiology programs at the Jubilant HollisterStier manufacturing facility. This role ensures compliance with regulatory requirements (e.g., FDA, EMA, Health Canada), supports client-specific quality standards, and drives continuous improvement in contamination control strategies. The manager will lead a team of microbiologists and EM technicians, and collaborate cross-functionally with manufacturing, quality assurance and validation. Responsibilities: Develop, implement, and maintain robust EM programs for cleanrooms, utilities (WFI, compressed gases), and personnel monitoring. Ensure timely execution of routine EM sampling, trending, and reporting. Investigate excursions and implement CAPAs to prevent recurrence. Microbiology Laboratory Management Oversee microbiological testing including bioburden, endotoxin, sterility, and microbial identification. Ensure laboratory compliance with GMP, GLP, and internal SOPs. Manage laboratory equipment qualification, calibration, and maintenance. Supervise and mentor EM and microbiology staff. Provide training and ensure competency in aseptic techniques and microbiological methods. Foster a culture of accountability, safety, and continuous improvement. Regulatory Compliance & Client Support Prepare for and support regulatory inspections and client audits. Author and review SOPs, protocols, and technical reports. Collaborate with clients to meet project-specific microbiological requirements. Contamination Control Strategy Lead contamination risk assessments and mitigation plans. Support aseptic process simulations (media fills) and cleanroom qualification. Participate in cross-functional investigations of microbiological deviations. Performs any other tasks assigned by Management. Key Interfaces: External: Internal: Quality, Production, Validation, Maintenance, Supply chain and any other required department. Education & Experience: Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry or related field. Experience Required: Minimum 5–7 years of experience in sterile pharmaceutical manufacturing, with at least 2 years in a leadership role. Strong knowledge of GMP, aseptic processing, and regulatory guidelines (e.g., USP , Annex 1). Experience in a CMO environment is highly preferred. Experience with regulatory inspections and audit readiness Excellent communication, organizational, and problem-solving skills. Skills Required: Thorough understanding of the pharmaceutical development process that leads through to commercial manufacturing and the associated GMP requirements. Computer literacy (Microsoft Office, SAP environment, and Electronic Data Acquisition System). Bilingual (French and English). Proficiency in English is essential. Detail-oriented with excellent analytical and communication skills. If qualified individuals with a disability need assistance in applying for this position, contact Human Resources at informing us regarding the nature of your request and providing your contact information. Join us, and be a part of our global success story #J-18808-Ljbffr