Sr Microbiologist-Steriliz

100% Remote
Microbiologist-Steriliz II
12 Months +Contract good potential of extension

Must Have:

Education Required: Bachelor of Science degree in Microbiology or related technical discipline Years of Experience: 15+ years industrial microbiology experience in the Medical Device or Pharmaceutical industry
Specialized Knowledge or Skills Required: Thorough familiarity with FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices.
Solid understanding of different types of sterilization methods (EtO, gamma, steam, etc.) including processes and equipment.
Proven leadership and knowledge in international and national standards such as AAMI/ANSI standards, E-Beam, ISO 17665 (Steam), 11137 (Radiation), 11135 (EtO) and others as applicable (i.e. EN). Specifically, Ethylene Oxide.
Excellent organizational and judgment skills. Ability to maintain and generate accurate records. Strong written, verbal communication skills.

Nice to Have:
Certified microbiologist or Certified Industrial Sterilization Specialist. (Ethylene Oxide/Radiation/Steam)
Computer proficiency using word processors, spreadsheet, and project management. Able to apply advanced scientific principles.
Good oral and written communication skills. Excellent presentation skills.
Must be able to handle multiple tasks/projects and manage business unit priorities accordingly. Must be able to work in a team environment, including cross-functional teams, and exert influence without alienating others.
Exceptional problem-solving skills, strong oral and written communications skills, and excellent interpersonal skills.
Working knowledge of statistical techniques

JOB DESCRIPTION
Responsibilities may include the following and other duties may be assigned. Analyzes chemical, biological or microbiological products, raw materials, inprocess materials, release test samples or stability samples in support of the company's quality program. Interprets and evaluates the analyses in terms of accuracy and precision compared aProductst established specifications and recommends and implements corrective action where necessary. Develops, validates, and implements controlled environment methods. Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation. May also be involved in establishing requirements for the transfer of methodology from R&D. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.