Sr Microbiologist-Steriliz - Exempt

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

• Analyzes chemical, biological or microbiological products, raw materials, in-process 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 against 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 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 in-depth in nature and often provides recommendations on process improvements.
• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.
• 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.

Must Have:

• Develop and executes sterilization validation protocols, manage work, document results in reports for contract ethylene oxide and radiation sterilization methods (ISO 11135 & ISO 11137): process definition, characterization, and validation.
• Ensures compliance to Good Manufacturing Practices specific to Buildings, Environmental Control, Cleaning and Sanitation and Personnel Practices. Assures compliance with all applicable international and domestic regulations and standards by defining policies, monitoring environmental control, and conducting necessary microbiology-related training.
• Provides sterilization technical expertise during change control activities, process modification studies, and failure investigations. Provides microbiological technical expertise during change control activities, process modification studies, and failure investigations regarding microbiological contamination control. Serves as technical liaison with functional groups, contract laboratories, and manufacturing sites.

Nice to Have:

• Certified microbiologist or Certified Industrial Sterilization Specialist.
• Working knowledge of statistical techniques.