At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Supply Chain Manufacturing **Job Sub** **Function:** Manufacturing Pharmaceutical Process Operations **Job Category:** Professional **All Job Posting Locations:** Incheon, Korea, Republic of **Job Description:** **About Innovative Medicine** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicines (IM) is looking for Manager, Process Microbiology and compliance. **Position Summary:** Responsible for the development and/or improvement and maintenance of the contamination prevention programs for the aseptic process in Incheon. Acts as the primary aseptic process SME and works with investigators on Aseptic process contamination control issues in the facility, and gives pragmatic advice to production operators, team leaders, and cross-functional management on topics concerning contamination risk mitigation. **Key Responsibilities** : + Comply with CREDO, EHS, and GMP regulations. + Drives improvements to reduce aseptic process contamination risks and enhance contamination control, ensuring successful implementation. + Provides valuable insights into aseptic techniques and behaviors throughout the production process, including areas such as equipment/facility design, cleaning and disinfection, gowning, and material transport within the facility. + Leads, participates in, and supports technical investigations of products or processes. + Leads and participates in Aseptic production process improvement projects. + Identifies and documents contamination-related risks in production processes and products, escalating them as necessary. + Takes proactive measures, based on risk analyses, observations, and deviations, to prevent contamination, ensuring implementation through follow-up and control + Reviews and/or approves technical documents, reports, and procedures. + Maintains a strong presence on the shop floor, closely collaborating with operators and management in cross-functional teams. + Leads the aseptic process monitoring council, a cross-functional meeting involving QC Microbiology laboratory personnel, Quality Assurance, Operations, MSAT, MAM, and compliance teams, to identify opportunities for improving aseptic process control. + Prepares for and provides aseptic process expertise during regulatory inspections as required. + Develops the technical knowledge of site personnel in aseptic process contamination control. + Responsible for creating, improving, and providing training and training curricula related to aseptic technique, behavior, and contamination control. + Participate in the local Sterility Assurance Team, contributing to the governance and implementation of contamination control strategies. + Production microbiologist and the facilitator of Sterility Assurance Team. **Minimum Qualification** + Minimally basic degree in Science, Engineering, and technical subjects. + Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external customers. + Excellent computer proficiency e.g., MS Office, SAP. + Excellent analytical skills to identify gaps and root causes of issues and think out of the box to develop a solution. + Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude. EDUCATION and/or EXPERIENCE: + A scientific background in Biology, Biochemistry, Microbiology, or related discipline, with 3+ years of related experience is required. + Requires thorough knowledge of applicable cGMP requirements. + Must have a detailed understanding of Large Molecule aseptic production processes(Drug Products) and critical process steps in relation to contamination control. + Experience on the shop floor in a pharmaceutical or biotechnological manufacturing environment. + Advanced knowledge and understanding of regulatory requirements, including Safety, QA, and QC functions, compliance requirements, and experience in regulatory inspections. + Must possess solid knowledge of the aseptic process, routine and non-routine environmental testing and sampling methods, techniques, and related equipment. + Experience in responding to FDA audits and CAPA development. LANGUAGE SKILLS: + Must be able to communicate effectively, clearly, and accurately in verbal and written English. + Must be able to write accurate, grammatically correct reports, business correspondence, and procedure manuals in English. (Local language capability is preferred) + Must be able to clearly and effectively present information and respond to questions from groups of managers and employees. + Provide effective and timely communication to all levels in the organization, as appropriately, within and outside of the department and to interact with external contacts. + Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups and/or boards of directors. Other requirements: + Must be able to effectively do and wear required primary and secondary gowning materials + Ability to deal with large amounts of complex information and often make critical decisions with limited information **Work Environment:** At Johnson & Johnson IM, we embrace a hybrid work model that effectively balances the advantages of in-office collaboration with the flexibility of remote work. For this role, you are expected to work on-site a minimum of 3 days per week. This on-site presence is vital for fostering collaboration and engaging with cross-functional teams, ensuring that quality remains at the forefront of our operations. The remaining days of the week may be reserved for remote work, providing flexibility while allowing for team interaction. **Legal Entity :** Janssen Vaccines **Job Type :** Regular **Application Documents :** Free-form resume AND cover letter is preferred (in Korean or English). **Application Deadline :** Open until the position is filled. **Notes** + Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws. + Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances. + If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted. + Submitted documents will not be returned and will be deleted upon request.