Ld Tech, Microbiology Development

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Job Functions

• Perform routine and non-routine microbiology/chemistry testing services which may include bioburden, BI & product sterility test, LAL bacterial endotoxin test, Microbial identification, EO residues test, using established procedures/protocols.
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
• Assist Microbiologist in creating and developing validation plans for laboratory equipment and methods.
• Participate in a team in laboratory investigations.
• Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data and may propose recommendation on template changes.
• Assist with routine manufacturing equipment validation by coordinating testing schedules and performing data analysis.
• Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations
• May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures
• Update test procedures and methods into system per recommendation by Microbiologist.
• Other incidental duties.

• Associate's Degree or equivalent 5 years of previous experience working in a laboratory or bachelor's degree in chemistry and /or Microbiology
• Laboratory experience (Bioburden, pyrogen, environmental tests)

• Excellent communication skills
• Able to read, comprehend, write and speak English and Spanish
• Excellent computer skills, including usage of MS Office Suite
• Full knowledge of laboratory processes, e.g., GLP (Good Laboratory Practices), ANSI (American National Standards Institute)/AAMI (Association for the Advancement of Medical Instrumentation) guidelines, British Standards, European Standards, Federal Standards, and USP Pharmacopeia.
• Full knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
• Full knowledge in mathematics, e.g., decimals, percentage, and statistics
• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Must be able to work in an inter-departmental team environment, as well as with colleagues from other departments
• Ability to provide feedback in a professional, direct, and tactful manner
• Accountable to adhere to applicable Environmental, Health and Safety and Quality System requirements to ensure our products and services consistently meet customer and regulatory requirements
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
• Ensure proper handling, storage and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests and coordinate proper training sessions to affected personnel