J&J Family of Companies
Senior Scientist MQSA
J&J Family of Companies, Santa Rosa, California, us, 95402
J&J Family of Companies Senior Scientist MQSA Santa Rosa, California Apply NowJohnson & Johnson is currently recruiting for a Senior Scientist of Microbiological Quality and Sterility Assurance (MQSA), supporting the Laminar business, located in Santa Rosa, CA. The position is eligible to participate in J&J Flex, working days both in the office and remote each week.
In this role, the Senior Scientist of Microbiological Quality and Sterility Assurance (MQSA) will support Laminar and Biosense Webster by performing complex (such as study lead for sterilization validation) and routine tests (such as environmental monitoring sampling of the clean rooms, water and air) in compliance with the laboratory test methods and procedures in order to provide support of New Product Development (NPD), Manufacturing, Regulatory, and other operational partners. The scientist will lead and support the sterility assurance and microbiology aspects of functional, project, and validation program deliverables to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards as they pertain to medical devices.
Key Responsibilities:
Serve as a liaison between the Microbiological Quality & Sterility Assurance (MQSA) team and operations execution team during the development and selection of sterilization modalities, cycle development, and process validations.
Work directly with the R&D teams to validate and transfer breakthrough technologies to enable future growth and innovations.
Drive selection of sterilization modality, validation approaches, and validation of the sterilization process for new products.
Support microbiological aspects of the control and monitoring of the manufacturing environment, including controlled systems such as clean compressed air and purified water.
Lead sterilization validations/revalidations studies or special projects as assigned.
Manage logistics of sterilization samples, review sterilization lot records, organize documents and submit for final release.
Collaborate with other Department representatives for special studies or routine functional issues.
Lead in the performance and/or troubleshooting of test method and equipment validation and training.
Qualifications
BS Degree in a biology, biochemistry, chemistry, microbiology, engineering, or a related field of study is required.
A minimum of 4 years of experience with knowledge of medical device company operations, quality standards and GMP regulations of a medical device or pharmaceutical company.
Strong technical writing skills, the ability to manage multiple projects simultaneously, and the ability to fluently change priorities based upon business need.
Experience with the use of ethylene oxide and at least one additional sterilization modality (e.g. radiation, moist heat, dry heat, etc.).
Qualified candidates will have experience in microbiology, sterilization validation, and environmental controls for a medical device or pharmaceutical manufacturing facility.
Good interpersonal and organizational skills.
Comfortable to work with multi-functional teams.
Strong attention to detail.
Preferred:
Masters Degree in science.
Experience with GMP audits, internal and relevant external audits.
Experience with overseeing biocompatibility studies.
Other:
Travel up to 15% may be required.
The anticipated base pay range for this position is $88,000- $141,450. Johnson & Johnson maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location:
NA-US-California-Santa Rosa
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In this role, the Senior Scientist of Microbiological Quality and Sterility Assurance (MQSA) will support Laminar and Biosense Webster by performing complex (such as study lead for sterilization validation) and routine tests (such as environmental monitoring sampling of the clean rooms, water and air) in compliance with the laboratory test methods and procedures in order to provide support of New Product Development (NPD), Manufacturing, Regulatory, and other operational partners. The scientist will lead and support the sterility assurance and microbiology aspects of functional, project, and validation program deliverables to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards as they pertain to medical devices.
Key Responsibilities:
Serve as a liaison between the Microbiological Quality & Sterility Assurance (MQSA) team and operations execution team during the development and selection of sterilization modalities, cycle development, and process validations.
Work directly with the R&D teams to validate and transfer breakthrough technologies to enable future growth and innovations.
Drive selection of sterilization modality, validation approaches, and validation of the sterilization process for new products.
Support microbiological aspects of the control and monitoring of the manufacturing environment, including controlled systems such as clean compressed air and purified water.
Lead sterilization validations/revalidations studies or special projects as assigned.
Manage logistics of sterilization samples, review sterilization lot records, organize documents and submit for final release.
Collaborate with other Department representatives for special studies or routine functional issues.
Lead in the performance and/or troubleshooting of test method and equipment validation and training.
Qualifications
BS Degree in a biology, biochemistry, chemistry, microbiology, engineering, or a related field of study is required.
A minimum of 4 years of experience with knowledge of medical device company operations, quality standards and GMP regulations of a medical device or pharmaceutical company.
Strong technical writing skills, the ability to manage multiple projects simultaneously, and the ability to fluently change priorities based upon business need.
Experience with the use of ethylene oxide and at least one additional sterilization modality (e.g. radiation, moist heat, dry heat, etc.).
Qualified candidates will have experience in microbiology, sterilization validation, and environmental controls for a medical device or pharmaceutical manufacturing facility.
Good interpersonal and organizational skills.
Comfortable to work with multi-functional teams.
Strong attention to detail.
Preferred:
Masters Degree in science.
Experience with GMP audits, internal and relevant external audits.
Experience with overseeing biocompatibility studies.
Other:
Travel up to 15% may be required.
The anticipated base pay range for this position is $88,000- $141,450. Johnson & Johnson maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location:
NA-US-California-Santa Rosa
#J-18808-Ljbffr