Job ID 21000B8C
Available Openings 1
Position Specific Information
Flexible- M-F, 8AM - 4:30PM
PURPOSE AND SCOPE:
Manages projects and validations including steam, EO and irradiation. Establishes sterilization validation plans and test requirements. Provides details and implements the testing, analysis and report writing for sterilization validations and coordinates analysis of cycle and vessel trends.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Provides a monthly report of activities performed on each assignment and track projects and coordinate resource needs.
- Maintains good documentation practices for all forms, logs, appendixes, protocols, reports, labeling, and laboratory notebooks. Prepares clear and informative engineering and technical reports with accuracy. Uses good documentation practices for record retention and change notices.
- Establishes and/or revises validation protocols, SVD's, SOP's, drawings, equipment specifications, Engineering Test Reports (ETR) and technical reports pertaining to sterilization.
- Proficiently performs testing and evaluation of process validations, various sterilization validations, and software validations.
- Self-motivated to improve knowledge related to process and sterilization validation techniques by continuous assessment of current publications, standards and regulations.
- Identifies, purchases and installs required instrumentation and equipment in support of sterilization validations. Develops, tests, and evaluates hardware/software recommendations in support of improvements to sterilization vessels or processes.
- Implements sterilization risk assessment, planning and evaluation as part of sterilization validations.
- Identifies corrective and preventative actions and root causes regarding sterilization discrepancies.
- Resolves sterilization process reviews, NCR's. and SPIF's
- Completes and reviews sterilization process cycle reviews as assigned.
- Manages, performs, and organizes validation/requalification and PM's for specific hardware, software, instruments, and environment relating to the sterilization process.
- Maintains compliance with applicable standards, local Standard Operating Procedures (SOP)'s and company policies.
- Understand and support design control projects relating to sterilization.
- Maintain a safe work environment for self and other employees.
- Maintain general housekeeping of working area and plant.
- May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.
- May refer to senior level staff for assistance with higher level problems that may arise.
- Escalates issues to supervisor/manager for resolution, as deemed necessary.
- Assist with various projects as assigned by direct supervisor.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Regularly required to talk or hear, stand, and walk. Frequently required to sit; use hands and fingers to handle, reach with hands and arms and wear personal protective equipment that may include steel-toed shoes, safety glasses, lab coat, chemical respirator, etc.
- Occasionally required to climb or balance, stoop, kneel, crouch, or crawl.
- Must regularly lift and /or move up to 15 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
- Frequently exposed to moving mechanical parts and risk of electrical shock; risk of radiation and vibration.
- Occasionally exposed to fumes or airborne particles; toxic or caustic chemicals wet and/or humid conditions.
- The noise level in the work environment is usually moderate.
Bachelor's Degree required
EXPERIENCE AND REQUIRED SKILLS:
- 2 – 5 years' related experience; or an advanced degree without experience; or equivalent directly related work experience.
- Ability to work independently.
- Must be able to prioritize responsibilities and establish time lines in order to maintain a balance of support in all projects and execute projects with clear objectives.
- Must be able to perform statistical analysis using statistic programs, and determine trends, and analytical evaluations.
- Ability to read, analyze, and interpret common scientific and technical reports, technical procedures, validation protocols and reports, operating instructions, general business periodicals, or governmental regulations or governmental regulations.
- Strong oral and written communication skills.
- Ability to work well with other departments and take an active role in team problem solving.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Proficient with PCs and Microsoft Office applications.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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