Validation Technician

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Job ID 21000MTJAvailable Openings 2Position Specific Information Monday - Friday Days, 40 hours per weekPURPOSE AND SCOPE: Coordinate, execute and complete various validations, projects and tasks as assigned. Perform duties to assist the Validation Supervisor and associated teams. PRINCIPAL DUTIES AND RESPONSIBILITIES: Under limited supervision, applies considerable knowledge to perform a broad range of tasks which include but are not limited to preparing various validation activities, requirements, and documentation. Assemble validation documentation, approvals, library maintenance, Standard Operating Procedures (SOP's), Specific Protocol Requirements (SPR), Deviation Notices (DN's), Bill of Materials (BOM's), Master Parts, Specification (MPS's), drawings, and Validated System Changes (VSC).Works on assignments that are moderately difficult, requiring judgment in resolving issues and/or in making recommendations. Support the validation and optimization of new and existing products developed from scale-up to commercialization. Prepare validation and performance qualification protocols, analyze data and prepare validation performance qualification summary reports. Monitor validation and performance qualification processes to ensure strict accordance with documentation. Operate and oversee various methods of sample preparations. Responsible for supporting engineers in their projects and assist with technical reports. Technician must adapt quickly to changing variables, to assure the best possible information is available for key decisions. Record test results on standardized forms and writes test reports describing procedures used. Work with other departments to ensure continuous improvement on product. Act as a validation/engineering representative with the other departments as required. Responsible for the quality and completeness of the total work product for his/her assigned shift. Provide an example of behavior and ethics to other technicians and ensure that all plant SOP's, policies and standards including, cGMP, ISO, and safety standards are followed. Complete Change control activities as assigned within a timely manner. Assist department personnel/management in planning and preparing new or revised documentation Ensure document redlines are correct and formatting follows set guidelines Assemble validation documentation to support document changes. Assist in updating and developing Standard Operating Procedures and Test Methods on current and new procedures. Contacts are frequently with individuals representing other departments, and/or representing outside organizations. Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of a sensitive nature. Normally receives no instruction on routine daily work, and general instructions on newly introduced assignments. May provide assistance to junior level staff with more complex support tasks that require a higher level of understanding of functions, as directed by immediate supervisor. May escalate issues to supervisor for resolution, as deemed necessary. Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. 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. While performing the duties of this job, the employee is regularly required to stand, walk throughout shift, use hands and fingers, handle or feel, reach with hands and arms; talk or hear and wear personal protective equipment that may include safety glasses, chemical resistant gloves, gloves, etc. The employee is occasionally required to sit; climb or balance and stoop, kneel, or crouch. The employee must regularly lift and /or move 10 to 25 pounds, frequently lift and/or move up to 50 pounds. While performing the duties of this job, the employee is regularly exposed to wet and/or humid conditions and fumes or airborne particles. The employee is frequently exposed to moving mechanical parts and toxic or caustic chemicals. The noise level in the work environment is usually moderate. EDUCATION: High School Diploma required; Associate’s Degree desirable EXPERIENCE AND REQUIRED SKILLS: 2 – 4 years’ related experience. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Should be able to write neat and legibly. Ability to write routine reports and correspondence in a professional manner. Ability to speak effectively before groups of customers or employees of organization. Ability to convey important information to those in management, to maintain high production quality. A strong numerical comprehension and adeptness at working with statistics, analyzing and manipulating data, and making recommendations. Strong project management skills. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to understand and manipulate a complex and dynamic process. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to react quickly and decisively. Must have the ability to handle several duties at one time. Word processing, spreadsheet software, Microsoft programs, and statistical applications software such as Minitab 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.,identifier:21000MTJ,qualifications: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. While performing the duties of this job, the employee is regularly required to stand, walk throughout shift, use hands and fingers, handle or feel, reach with hands and arms; talk or hear and wear personal protective equipment that may include safety glasses, chemical resistant gloves, gloves, etc. The employee is occasionally required to sit; climb or balance and stoop, kneel, or crouch. The employee must regularly lift and /or move 10 to 25 pounds, frequently lift and/or move up to 50 pounds. While performing the duties of this job, the employee is regularly exposed to wet and/or humid conditions and fumes or airborne particles. The employee is frequently exposed to moving mechanical parts and toxic or caustic chemicals.  The noise level in the work environment is usually moderate. EDUCATION: High School Diploma required; Associate’s Degree desirable   EXPERIENCE AND REQUIRED SKILLS:    2 – 4 years’ related experience. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Should be able to write neat and legibly.  Ability to write routine reports and correspondence in a professional manner.  Ability to speak effectively before groups of customers or employees of organization. Ability to convey important information to those in management, to maintain high production quality. A strong numerical comprehension and adeptness at working with statistics, analyzing and manipulating data, and making recommendations. Strong project management skills. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to understand and manipulate a complex and dynamic process.  Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to react quickly and decisively.  Must have the ability to handle several duties at one time. Word processing, spreadsheet software, Microsoft programs, and statistical applications software such as Minitab 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.,title:Validation Technician,url:****Medical Care},jobLocation:{@type:Place,address:{@type:PostalAddress,addressLocality:Ogden,addressRegion:UT,addressCountry:United States,streetAddress:,postalCode:84404}}}

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