Validation Technician

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13594679

## Who We Are

Fagron is the global market leader in pharmaceutical medicine, and its

products are sold to more than 200,000 customers in over 60 countries.

The goal of Fagron is: Together we create the future of the personalized

medicine. Fagron, together with prescribers, pharmacists, and customers,

strives to improve medications and help the patient. From our position

as market leader, we act locally and think internationally.

## About the Job

[The Validation Technician executes anddocumentscalibration,

qualification, and validation activities that support sterile drug

manufacturing within a 503B outsourcing facility.This role ensures

equipment, utilities, and controlled environments operate in compliance

with FDA, cGMP, and data integrity

requirements.]{contrast="none"}[]{ccp-props="{"}

• [Key Responsibilities]{contrast="none"}**[]{ccp-props="{"}
• [Perform calibration, qualification (IQ/OQ/PQ), and routine
  
  

requalification of manufacturing equipment, utilities, and critical

instruments.]{contrast="none"}[]{contrast="none"}[]{ccp-props="{"}

• [Execute approved validation protocols and generate compliant final
  
  

reports.]{contrast="auto"}[]{ccp-props="{"}

• [Supportvalidationlifecycle activities, including risk assessments
  
  

and periodic reviews.]{contrast="auto"}[]{ccp-props="{"}

• [Operate andmaintainvalidationdata acquisition systems (e.g., Kaye
  
  

AVS).]{contrast="auto"}[]{ccp-props="{"}

• [Document all activities according to ALCOA data integrity
  
  

principles.]{contrast="auto"}[]{ccp-props="{"}

• [Maintain calibration/validation databases with NIST
  
  

traceability.]{contrast="auto"}[]{ccp-props="{"}

• [Coordinate external contractors for cleanroom
  
  

certification.]{contrast="auto"}[]{ccp-props="{"}

• [Troubleshoot and perform minor repairs on instruments and
  
  

equipment.]{contrast="auto"}[]{ccp-props="{"}

• [Ensure compliance with 21 CFR Parts 210/211 and internal quality
  
  

systems.]{contrast="auto"}[]{ccp-props="{"}

• [Support investigations with technical data and root cause
  
  

analysis.]{contrast="auto"}[]{ccp-props="{"}

## Basic Qualifications

• [AS degree ina technical/engineering/pharma discipline or equivalent
  
  

experience.]{contrast="none"}[]{ccp-props="{"}

• [24years experiencein pharmaceutical or sterile manufacturing; 503B
  
  

preferred.]{contrast="none"}[]{ccp-props="{"}

• [Knowledge of cGMP, validation principles, cleanroom operations, and
  
  

aseptic processing.]{contrast="none"}[]{ccp-props="{"}

• [Familiarity with USP, ISPE, PDA, andFDAsterile compounding
  
  

guidance.]{contrast="none"}[]{ccp-props="{"}

• [Strong documentation skills in regulated
  
  

environments.]{contrast="none"}[]{ccp-props="{"}

• [Effective communication and ability to collaborate
  
  

cross-functionally.]{contrast="none"}[]{ccp-props="{"}

## What\'s on Offer?

We offer a dynamic environment where talent and ambition can develop to

its fullest. We have an open and informal organization culture, where

individuals need to have strong motivation and ability to work

independently. Fagron is a widely expanding, international,

professional, and ambitious pharmaceutical company with multiple growth

opportunities. Job opportunity includes competitive salary,

comprehensive benefits, performance package, and ability to be part of

an international leader in an expanding industry.

## Ready for the challenge?

Fagron US is committed to creating a diverse environment and is proud to

be an equal opportunity employer. All qualified applicants will receive

consideration for employment without regard to race; creed; color;

religion; national origin; sex; age; disability; sexual orientation;

gender identity or expression; genetic predisposition or carrier status;

veteran, marital, or citizenship status; or any other status protected

by law. Fagron US is proud to be an affirmative action and equal

opportunity employer.