Validation Engineer 2 - (US) - Validation Engineer II - Fresenius Medical Care Holdings, Inc.

PURPOSE AND SCOPE:

Supports validation protocols and validation performance qualification summary reports. Maintains 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:

• Completes 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.
• Proficiently develops and performs testing and evaluation of process validations and software validations in compliance with all Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualification (PQ). Documents all activities appropriately.
• Evaluates and executes validation/requalification.
• Maintains and assists in establishing standardized methods and procedures for software, process, and test method validations and ensure standardized methods are implemented and followed.
• Maintain 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.
• Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors.  Exercises judgment within defined procedures and practices to determine appropriate action.
• May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.
• Provide technical support and expertise to other departments.
• 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.
• 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.
• 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 - 20% may be required.

EDUCATION:

Bachelor's Degree required, preferably in Mechanical, Electrical, Electromechanical, or Biomedical Engineering.

EXPERIENCE AND REQUIRED SKILLS:        

• Minimum 2 - 5 years of related experience; or an advanced degree without experience.
• Good working knowledge of production processes, SOPs, drawings, machine specifications, and required test equipment/fixtures.
• 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.
• Ability to write reports, business correspondence, and procedures. Must be able to prepare clear and informative engineering and technical reports with accuracy.
• Ability to work with mathematical concepts such as 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.
• Ability to define problems, collects data, establish facts, and draw valid conclusions.
• Ability to effectively present information to upper management and other groups.
• Capable of working independently and is self-motivated to improve skill set related to recognized process validation techniques.
• Effective in written and verbal communications.
• Good understanding of software management Tools, spreadsheets, and word processing software.
• Ability to apply logical and scientific critical thinking to a wide range of intellectual and practical problems.
• Understanding of relationship between medical device manufacturer and regulatory agencies which monitor them.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

ADDENDUM:

Engineering/Utilities focus

• Understand corrective and preventative actions, and root cause analysis.
• Provides reports of activities, assists in troubleshooting and informs management of any unusual conditions.
• Knowledge of usage, repair, storage, calibration of monitoring devices, and other instrumentation used by FMC as needed.
• Fundamental knowledge of PLC software development language and programming principles.  

Engineering/Quality focus

• Assists in the definition and support of appropriate AQLs and sampling plans used throughout the plant, and ensure that they are established with the appropriate documented rational. 
• Assesses and document the needs for improvement to statistical methods deployed across the plant.
• Updates applicable procedures to ensure the availability of the most appropriate tools for statistical analysis.
• Establishes necessary training modules for, and train personnel on, the proper use and application of implemented statistical methods across the plant.
• Familiarity with quality and statistical tools.

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.

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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.