Prin Microbiologist-Steriliz

Prin Microbiologist-Steriliz Job Summary: Talent Software Services is in search of a Prin Microbiologist-Steriliz for a contract position that can be worked 100%. The opportunity will be six months with a strong chance for a long-term extension.

Position Summary: Principal Microbiologist-Sterilization Specialist Interfaces with diverse cross-functional team members to define and oversee environmental and sterilization control policies to assure that Healthcare medical devices consistently comply with microbiological and particulate contamination control requirements, standards, guidelines and industry practices, both domestic and international. Primary Responsibilities/Accountabilities:Develop and executes sterilization validation protocols, manage work, document results in reports for contract ethylene oxide sterilization and radiation methods (ISO 11135 & ISO 11137): process definition, characterization, and validation.

Provides microbiological technical expertise during new product development 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.

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:

Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area.

Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area.

Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking.

Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Qualifications:10 years applied experience in contract ethylene oxide and radiation sterilization, specifically execution of validations and optimization of cycles (ISO 11135 and 11137) Exceptional problem-solving skills, strong oral and written communications skills, and excellent interpersonal skills. Ability to multi-task, Skilled in planning, organizing, coordinating projects and working independently Education/Years' Experience Required: Requires a University Degree and minimum of 10 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.

May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. Preferred:Degree in Microbiology, Chemistry, or similar field Certified microbiologist or Certified Industrial Sterilization Specialist. 10 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. If this job is a match for your background, we would be honored to receive your application Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement. Let's talk