Responsibilities may include the following and other duties may be assigned.

Work with single use devices and will need to have hands-on experience with product bacterial endotoxin programs and Ethylene oxide sterilization. Practical experience with sterilization, microbiology and controlled environments. Standards and guidances applicable for this role include, but are not limited to, ISO 11135, ANSI/AAMI ST72, ISO 11737-1 and -3, ISO 14644 (series), EN 17141.

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 2 years of relevant experience, or advanced degree with a minimum of 1 years relevant experience.