Microbiology Analyst II

Job description

Janssen Ortho LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for Microbiology Analyst II to be based in Gurabo, PR site.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

As the Microbiology Analyst II, you will:
• Prepare culture media, reagents, stock culture and materials required for testing.
• Perform Water sampling & analyses in accordance with internal and external regulations and policies and consistent with supply chain cycle time goals.
• Execute microbiological testing associated with the release of raw materials, products and utilities (i.e. water, compressed gases, clean steam etc.) according to internal and compendia specifications.
• Keep trend analysis up-dated in a monthly/quarterly basis.
• Work on test methods validation for all raw materials, drug substances and products as required.
• Participate in internal and external audits when required.
• Conduct the environmental monitoring of manufacturing areas.
• Perform biological indicators test, antimicrobial effectiveness test, endotoxin, and media preparation and growth promotion tests.
• Support investigations or risk assessments when questionable microbiological results have been generated.
• Perform all laboratory activities under cGMP's practices and compliance policies. Assure the compliance to all quality control policies, procedures and systems to ensure the timely release of high quality product in support the supply chain process.
• Report results and/or deviations associated in a clear, concise and accurate manner.

Desired profile

Qualifications :

• A bachelor's or higher degree in Science with a major in Microbiology, Biology, Biotechnology or Natural Sciences is required.
• At least two (2) years of experience in Microbiology laboratories within the regulated industry (pharmaceutical, biotechnology, medical devices or consumer) industry is required.
• Knowledge of current Good Manufacturing Practices (cGMPs) within the regulated industry is required.
• Previous experience in technical writing is highly preferred.
• Basic computer management skills in MS Office programs (Word, Excel, Outlook) are required. Proficiency in LIMS or similar Laboratory management system is preferred.
• Fluency in English and Spanish (oral and written) is required.
• Must be able to work extra hours, at night or on week-ends and irregular shifts. Able to respond to emergency calls and to support other departments or projects according to business needs.
• Availability to travel approximately ten percent (10%) of the time is required.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.