BSL Scientist Sr. I

Requisition ID: 59027  Title: BSL Scientist Sr. I  Division: Arthrex Manufacturing Inc (US02)  Location: Ave Maria, FL 

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a BSL Scientist, Sr. I who is responsible for performing laboratory testing and activities according to procedures to support monitoring programs and manufacturing activities at our Ave Maria, FL site. The BSL Scientist, Sr. I acts as a Biological Safety representative to consult and perform the necessary analysis for the safe release of products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Essential Duties and Responsibilities:

• Develop and validate microbiological and/or Analytical test methods per ISO/USP with specific emphases on Laboratory QMS.
• Proceduralize microbial and analytical tests as necessary to support orthopedic device requirements and production needs.
• Establish testing and reporting quality standards in compliance with ISO/IEC 13485 and 17025 for Arthrex laboratory testing activities.
• Track, trend, and provide statistical analysis for testing data related to the monitoring and maintenance of manufacturing operations, and the associated special process outputs.
• Enforce corporate specifications for monitoring and maintenance of production and environment standards necessary to maintain the safety of Arthrex products.
• Evaluate and optimize Arthrex current work instructions and specifications to ensure clear and efficient communication of biological safety standards and requirements for internal and supplier-based manufacturing operations.
• Identify, develop, and deliver training specifically related to requirements for continued maintenance of the biological safety of medical devices and the impact of those requirements on the manufacturing processes.
• Assist in the development, implementation, and continued maintenance of LIMS.
• Perform testing to improve efficiencies and optimize workflow.
• Act as a SME to advise the manufacturer on testing requirements to ensure Biological Safety and regulatory compliance.

 

Education and Experience:

 

Bachelor’s Degree in Microbiology, Chemistry, or Science Related study required.

5+ years of relevant experience required

Experience working and operating Laboratory Information Management Systems (LIMS) required

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Knowledgeable of cGMP, ISO, and USP guidelines for testing of medical devices required.
• Working knowledge of microbial identification & Characterization, Bioburden, LAL, Cytotoxicty techniques preferred, and/or working knowledge of analytical chemistry techniques, (i.e. GC, GC-MS, LC-MS, FTIR, etc.) required.
• Knowledge of method development and validation experience for analytical instrumental technique and microbial technique preferred

 

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company).  Perkin Elmer instrument software experience/knowledge is highly desirable.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. 

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. 

 

Vision Requirements:

Visual acuity necessary to