Validation Specialist in Albuquerque, NM at AMRI

Date Posted: 12/11/2019

Job Snapshot

Job Description

Validation Specialist

Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 

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 part 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 release of equipment, systems, instruments, components, 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 validations 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 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 to management course of action when critical instruments, systems or processes are found to be out of specifications.
  • Interacts as needed with outside vendors and consultants. 
  • Other duties may be assigned
Supervisory Responsibilities:                                              
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

Job Requirements

Education and/or Experience:                                            
B.S. in Computer Engineering or Physical Sciences (or equivalent) with a minimum of two years 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.
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 by 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.

Shift:  Standard 8

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.