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Validation Specialist - ABQ

Company: Curia
Location: Amityville
Posted on: March 20, 2023

Job Description:

Summary:

The Validations Department is responsible for formulating, reviewing, and approving all validation protocols related to manufacturing and quality operations and providing guidance to production and quality regarding equipment, component, process, and system-related functions.

Responsible for computer-related system validations and assurance of GxP compliance to 21 CFR parts 210, 211, and 820. Ensures change controls, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP) and meet applicable GAMP requirements. Coordinates validations with section supervisors to ensure timeliness with minimal disruption of production schedules. Writes validation protocols, final reports, and summaries of work for the release of equipment, systems, instruments, components, and utilities tested.

Essential Duties and Responsibilities:

  • Writes computer-related system validation protocols, manufacturing equipment, and master plans and supervises and/or performs testing related to computer-related system validation. Writes, assesses, and summarizes lyophilizer qualification protocols. Writes packaging equipment validation protocols and master plans and supervises and/or performs testing related to packaging equipment validation.
  • Monitors the qualification and validation process to determine accuracy and reliability of equipment, systems, instruments, and processes; and effects repairs/adjustments and changes based on results. Analyzes data and writes and/or reviews final reports and summaries for validation protocols. Develops, reviews, and recommends changes to validation procedures.
  • Conducts special projects as directed by management. Provides technical advice on new equipment and systems and modification to existing equipment and systems to ensure validation/certification and servicing can be provided. Provides technical assistance and training for personnel.
  • Schedules validations with section supervisors to ensure timely completion with minimal disruption of the production schedule. Recommends changes in policies and procedures, to management, to enhance the company's ability to conform to directives and regulations. Notifies and recommends a management course of action when critical instruments, systems, or processes are found to be out of specification. Interacts as needed with outside vendors and consultants. Other duties may be assigned

    Supervisory Responsibilities:

    None

    Education and/or Experience:

    B.S. in Computer Engineering or Physical Sciences (or equivalent) with a minimum of two (2) years of directly applicable experience. Must have experience in high-level mathematics (i.e., calculus) and technical writing. Knowledge of regulations FDA, ISO 9000-3, PIC/S guides to cGMP, GAMP4, and GAMP 5 based on GAMP V-Model Framework, EUGMP Annex 11 "Computer Systems."

    Language Skills:

    Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

    Mathematical Skills:

    Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. . Ability to comprehend and apply principles of calculus, modern algebra, and statistics. Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations.

    Reasoning Ability:

    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.

    Computer Skills:

    To perform this job successfully, an individual should know Database software; Internet software; Spreadsheet software, and Word Processing software

    Other Skills and Abilities:

    Ability to read, analyze, and interpret professional journals, SOPs, technical procedures, or governmental regulations. Ability to write protocols, reports, business correspondences, and procedure manuals. All communication must be in English. Ability to comprehend and apply principles of calculus, modern algebra, and statistics. Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations. Computer Skills: Ability to utilize MS Office, Databases, and preferably PLC Ladder Logic.

    Other Qualifications:
  • Must pass a background check
  • Must pass a drug screen

    Physical Demands:

    While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use their hands to handle or feel. The employee is occasionally required to stand, walk, and reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.

    Work Environment:

    While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation, and vibration. The noise level in the work environment is usually moderate.

    All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

    Note

    This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship.

Keywords: Curia, New Haven , Validation Specialist - ABQ, Other , Amityville, Connecticut

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