Lyophilzation Technician -B Shift - ABQ

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

Job Description:

Summary:

The lyophilization department is responsible for the clinical and commercial lyophilization function within the site. This includes the operation of lyophilization equipment and participation in production activities relating to lyophilization. The lyophilization department ensures that standard operating procedures (SOP's) and current good manufacturing practices (cGMPs) are followed at all times. The lyophilization department completes all associated master batch record (MBR) documentation and assists in the development and review of SOP's relating to the department, completing all associated quality reporting documentation.

The lyophilization technician is part of a team responsible for the daily duties of ensuring the lyophilizers are cleaned, sterilized, and leak tested before manufacturing of the product, operates the lyophilizers according to specifications, monitors cycles, and reviews data to ensure requirements have been met and completes all associated documentation. Cleaning operations occur in a cleanroom environment and are governed by strict standards of sterility and regulatory agencies.

Essential Duties and Responsibilities:

• Ensures lyophilizers are cleaned, sterilized, and leak tested before manufacturing the product. Operates lyophilizers according to the product specifications including temperature, pressure, time, etc. Monitors lyophilization cycles and reviews data to ensure requirements of product SOP's have been met.
  
• Communicate with production and engineering staff about the status of lyophilizer operations. Assists other shifts as needed. Understands and follows cGMP.
  
• Understands and follows safety practices. Other duties as specified by the Lyophilization Supervisor. Comprehend and follow SOP's, cGMPs, and good aseptic techniques to produce sterile quality products.
  
• Aseptic gowning for various classifications of cleanroom areas. Documentation and review of associated paperwork for accuracy and clarity. Working with peers to help train each other as directed by Production Management. Other miscellaneous duties as required by supervisor.
  
  Supervisory Responsibilities:
  
  This job has no supervisory responsibilities
  
  Education and/or Experience:
  
  High school diploma or general education degree (GED) combination of education and experience with a minimum of less than two (2) years of experience in a manufacturing/production environment. Requirement:
  
  Language Skills:
  
  Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Understand, Interpret and apply technical writing and instruction .
  
  Mathematical Skills:
  
  Ability to apply math and physic science concepts .
  
  Reasoning Ability:
  
  Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
  
  Computer Skills:
  
  To perform this job successfully, an individual should have knowledge of Manufacturing software; Spreadsheet software, and Word Processing software. Working knowledge of MS Office.
  
  Other Skills and Abilities ;
  
• Must be able to follow detailed instructions, utilize good written/communication skills, and have some basic computer skills.
  
• Ability to perform documentation duties and projects that relate solely to the filling department.
  
  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 hands to finger, handle, or feel. The employee is occasionally required to stand; walk; 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 , Lyophilzation Technician -B Shift - ABQ, Professions , Amityville, Connecticut