Engineer Microbiology and Compliance

at  Johnson Johnson

Engineer Microbiology and Compliance (f/m/d)
Caring for the world, one person at a time… inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
Janssen Vaccines in Bern (Switzerland) belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 30,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 300 people of over 20 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products. We are committed to bringing meaningful innovation to global health by combating major threats to the health of people worldwide.

Main Responsibilities

• This role is to provide expertise in the development, deployment, and maintenance of procedures for contamination control, aseptic processing, and sterility assurance, such as zone concept, environmental and utilities monitoring (including trending), clean rooms cleaning, material hygiene, and gowning all in accordance with corporate and health authority regulations.
• Provide the site with microbiological expertise for cleanroom environment/purified water systems routine testing programs.
• Provide microbiological expertise to the Qualification and Validation teams to ensure appropriate performance-qualification (PQ) of cleanrooms and utilities.
• Ensure that new manufacturing processes, or process changes meet biocontamination control principles and sterility assurance requirements.
• Lead E2E contamination control-related investigations (out of specification; out of limit; and out of trend results) Perform root cause analysis, action plan setting, implementation, and effectiveness.
• Responsible for achieving harmonized and in compliance Contamination control processes on site
• Setting microbiological KPIs and metrices
• Train and qualify operators with current procedures and best practices.

Support the site during audits/inspection for Micro processes and Sterility Assurance topics

QUALIFICATIONS

Who we are looking for

• A minimum of a bachelor’s degree in microbiology, biology, engineering, or equivalent pharma discipline.
• 3+ years of experience in a GMP environment, in a pharmaceutical, or similar regulated industry with detailed knowledge of relevant regulations and standards
• Microbiological Quality and Sterility assurance expertise.
• Understanding of contamination control for manufacturing processes and thorough knowledge in cleanrooms environments.
• Experience in the requirements for pharmaceutical utilities (i.e., purified water systems, pharma-grade gases, steam)
• Demonstrated collaborative nature and proactive communication skills to work efficiently and effectively in a diverse community on cross-functional project teams
• Excellent organizational and time management skills

• This role is to provide expertise in the development, deployment, and maintenance of procedures for contamination control, aseptic processing, and sterility assurance, such as zone concept, environmental and utilities monitoring (including trending), clean rooms cleaning, material hygiene, and gowning all in accordance with corporate and health authority regulations.
• Provide the site with microbiological expertise for cleanroom environment/purified water systems routine testing programs.
• Provide microbiological expertise to the Qualification and Validation teams to ensure appropriate performance-qualification (PQ) of cleanrooms and utilities.
• Ensure that new manufacturing processes, or process changes meet biocontamination control principles and sterility assurance requirements.
• Lead E2E contamination control-related investigations (out of specification; out of limit; and out of trend results) Perform root cause analysis, action plan setting, implementation, and effectiveness.
• Responsible for achieving harmonized and in compliance Contamination control processes on site
• Setting microbiological KPIs and metrices
• Train and qualify operators with current procedures and best practices