Sr Microbiologist Scientist.US-PBF.001

Overview:
Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.But that's just the beginning. Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours. At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra's ongoing commitment to our values and our shared success. Integra's health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both. Regardless of geographic location, our commitment is to offer the following, whenever possible:Benefit plans that meet all local statutory requirementsA range of programs that reflect typical local market practicesAn opportunity for employees to tailor benefits to their specific needsBenefits that balance employee's short-term and long-term needsClick HERE for more information regarding our benefits and total rewards program

Responsibilities:
The Senior Microbiology Scientist provides technical support, both within and outside of the Quality Control team, for all matters related to Microbiology, including product sterilization, microbiological testing, and cleanroom environmental monitoring. Performs functions such as executing laboratory testing and data analysis, test method development, validation development and implementation, and investigations. Provide guidance and mentoring to junior lab members. This position is responsible for the development, implementation, and monitoring of products in compliance with all applicable corporate and regulatory policies. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive.Serve as subject matter expert for matters related to product sterility assurance, including product terminal sterilization methods, product Bioburden and Sterility testing, and cleanroom contamination control.Oversee all routine sterility assurance activities, including product Bioburden testing, sterilization verification dose audits, and sterilization cycle revalidations. Coordinate with Operations and Planning teams to schedule and track manufacture of testing samples to fulfill these requirements.Train and supervise Microbiology Lab analysts on scheduling and execution of routine Bioburden and Dose Audit testing.Author and/or review reports for sterilization validations, sterilization cycle assessments, Bioburden Alert/Action limit assessments, etc.Communicate directly with sterilization facilities and third-party labs to schedule sample submission and troubleshoot sterilization or testing deviations.Provide technical support throughout the organization and lead investigations to resolve issues regarding product Microbiological testing, sterilization processes, cleanroom environments, and other Microbiology-related matters.Write investigations to identify root causes for non-conformances and recommend corrective actions to support and improve production. Drive assigned CAPA to closure. Lead and/or participate in projects to develop and implement new laboratory test methods, laboratory equipment, sterilization processes, environmental monitoring plans, etc.Train manufacturing personnel on cleanroom behavior, material transfer, and other aseptic techniques to aid in contamination control.Update and/or create Standard Operating Procedures (SOPs).Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.Assist with proper execution of laboratory Alert/Action (AA) and Out-of-Specification (OOS) investigations. Review AA and OOS investigations as needed. Review test data and report any deviations to supervisor. Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.Perform other related duties as required.

Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:Bachelor's degree, in Microbiology, Biology, or related field.7+ years of relevant GMP/GLP laboratory experience in regulated industry. Capable of both written and verbal effective communications skills including presentations.Demonstrate organizational and time management skills.Must be able to work independently with minimal supervision.Knowledge of MS Office Suite.The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee mustspeak and write in English. The employee is required to go to all areas of the company, including the manufacturing cleanrooms. The employee may be required to stand for up to 4 hours at a time. The employee may be required to periodically lift up to 25lbs. In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.