Fresenius Medical Care Holdings, Inc.
Receive alerts when this company posts new jobs.
Validation Engineer I
at Fresenius Medical Care Holdings, Inc.
PURPOSE AND SCOPE:
Supports validation protocols and validation performance qualification summary reports. Assists with maintaining the validation system; monitors the validation status of equipment, processes, and test methods, and ensures the validation activities are made in adherence to local and corporate validation procedures.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Under close supervision, utilizes established procedures to perform routine assigned tasks to complete projects as assigned by the department manager. 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.
- Generates and revises validation protocols, SOPs, drawings, equipment specifications, Engineering Test Reports (ETR), and technical reports.
- Provides monthly report of activities performed on each assignment; tracks projects and coordinates resource needs.
- Assists with developing and performing testing and evaluation of validations in compliance with Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualification (PQ). Documents all activities appropriately.
- Maintains good documentation practices for all forms, logs, appendices, protocols, reports, and laboratory notebooks.
- Evaluates and executes validation/requalification.
- Maintains and assists in establishing standardized methods and procedures and ensures standardized methods are implemented and followed.
- Maintains compliance with applicable GMP standards, ISO Standards, local Standard Operating Procedures (SOP)'s and company policies. Maintain a safe work environment for self and other employees.
- Assists in establishing and/or revising validation protocols, SVD's, SOP's, drawings, equipment specifications, Engineering Test Reports (ETR).
- Assists department personnel in troubleshooting process problems.
- Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
- Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Builds stable working relationships internally.
- May refer to higher level staff, if applicable, for assistance with day-to-day problems that may arise.
- Escalates issues to supervisor/manager for resolution, as deemed necessary.
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- Our Company Values: Honesty & Integrity, Quality, Respect & Dignity, Innovation & Improvement, Teamwork & Safety are the guiding principles of employee behavior at FMCNA.
- Maintains general housekeeping, as needed, of working area and plant.
- Assists 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.
- Occasionally exposed to moving mechanical parts and vibration. Occasionally exposed to fumes or airborne particles and toxic or caustic chemicals and risk of electrical shock.
- The noise level in the work environment is usually moderate.
- Ability to lift and/or move up to 50 lbs.
- Frequently exposed to moving mechanical parts and wet and/or humid conditions. Occasionally exposed to fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; risk of radiation and vibration.
- Travel 10% may be required.
Bachelor's Degree required, preferably in Mechanical, Electrical, Electromechanical, or Biomedical Engineering; in lieu of Bachelor's Degree, Associate's Degree may be acceptable with additional relevant experience and/or training.
EXPERIENCE AND REQUIRED SKILLS:
- Minimum 0 – 2 years of related experience.
- Good working knowledge of production processes, SOPs, drawings, machine specifications, and required test equipment/fixtures.
- Learns to read, analyze, and interpret common scientific and technical reports, technical procedures, validation protocols and reports, operating instructions, general business periodicals, or governmental regulations.
- Capable of working independently and is self-motivated to improve skill set related to recognized process validation techniques.
- Learns to write reports, business correspondence, and procedures.
- Understanding of relationship between medical device manufacturer and regulatory agencies which monitor them.
- Good verbal communication skills are essential.
- Effectively present information and respond to questions from management, public groups, etc.
- Works well with engineers and personnel from other departments and takes active role in team problem solving.
- Ability to work with basic mathematical concepts and has ability to learn probability, statistical inference, and fundamentals of plain and solid geometry and trigonometry on a scientific level. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Learns to define problems, collect data, establish facts, and draw valid conclusions. Apply principles of logical or scientific thinking to a wide range of situations. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Uses analysis and troubleshooting techniques to solve problems related to manufacturing processes and product design.
- Fundamental knowledge of PLC software development language and programming principles.
- Knowledge of database software; spreadsheet software and word processing software.
- Ability to troubleshoot basic process related equipment when necessary to accomplish validations and other related projects.
- Ability to pass a basic color vision test (Ishihara Color Test) either in conjunction with a routine eye exam or performed by Fresenius Medical Care HR or Nurse. A doctor's note or a memo will serve as documentation and will be added to the employee HR file.
- Reference ComplianceWire Curriculum.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Ogden Manufacturing - Sterilization
- Supports plant sterilization and validations including steam, ETO, and radiation. Assists in executing sterilization validation plans and test requirements.
- Provides details and implements, as required, the testing analysis and assists in report writing for sterilization validations. Responsible for providing support of special projects or process improvement projects.
- Maintains instrumentation and equipment in support of sterilization validations.
- Assists in developing, testing, and evaluating hardware/software recommendations in support of improvements to sterilization vessels or processes. Maintains laboratory notebook and data binders, test results, raw data sheets according to cGLP.
- Assists in sterilization validations/requalification.
- Completes/reviews sterilization process cycle reviews or irradiation certifications as assigned.
- Calibrates, maintains, and manages thermal and humidity data gathering devices.
- Self-motivated to improve knowledge related to process and sterilization validation techniques. Provide technical support to other departments.
Concord Manufacturing - Quality Systems Validation
- Maintain master validation plan and master validation list up to date.
- Create and review validation documents following guidelines established in systems validation procedures.
- Provide clear and concise monthly status reports of projects and objectives.
- Serves as a subject matter expert (SME) and provides training related to systems validation.
- Create, maintain and distribute performance metrics.
- Keep track of opening, development and closure of validation documents.
- Maintain periodic reviews on time.