Sr Microbiologist

Top 3:

1. 7+ years applied experience in contract ethylene oxide and radiation sterilization, specifically execution of validations and optimization of cycles (ISO 11135 and 11137)

2. Exceptional problem-solving skills, strong oral and written communications skills, and excellent interpersonal skills.

3. Ability to multi-task, Skilled in planning, organizing, coordinating projects and working independently

Education/Years' Experience Required: Requires a University Degree and minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Position Description:

Senior Microbiologist-Sterilization Specialist Interfaces with diverse cross-functional team members to define and oversee change control actions for sterilization control policies to assure that client's medical devices consistently comply with microbiological and sterilization requirements, standards, guidelines, and industry practices, both domestic and international.

Responsibilities

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.

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.

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.

Conducts OTR (Out of Tolerance Result) investigations, establishes actions to address OTR and reviews output of OTR Investigations with Quality Management.

Communicates detailed information regarding required policies and monitoring results to Manufacturing and Quality Assurance Managers. Establishes trends; recommends revisions to monitoring program and/or manufacturing process controls. Ensures effective corrective actions are implemented, where necessary.

Provides microbiological technical expertise to the Facilities department regarding cleaning and contamination control.

Assures timely, accurate and independent evaluation of product compliance to sterilization, and microbiology requirements.

Supports Regulatory Affairs and other departments by providing technical input on sterilization, and microbiology related content of regulatory submissions and departmental procedures.

Willing to travel with minimum advanced notice.

Nice to Have

Degree in Microbiology, Chemistry, or similar field

Certified microbiologist or Certified Industrial Sterilization Specialist.

7+ year's industrial microbiology experience in the Medical Device or Pharmaceutical industry.

Working knowledge of statistical techniques

Knowledge of applicable ASTM, ISO, FDA and EN regulatory standards.

Exceptional problem-solving skills, strong oral and written communications skills, and excellent interpersonal skills.

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.

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 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 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.