Senior Validation Engineer

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

information, please see: https://www.kansasworks.com/jobs/13643952

## Who We Are

Since 1990, weve grown into a global leader in personalized medicine.

Today, our 5,000 energetic employees are based in 80 locations in

Europe, North America, South America, Africa and Asia-Pacificand are

working together to support over 200,000 customers worldwide.

From compounding and natural products to software, equipment, and

genomics we deliver smart, ready-to-use solutions that make healthcare

better.

Were passionate, science-driven, and always looking for new ways to

improve lives. ??

Explore your future at[Fagron Career

Site](https://fagron.jobsmarket.site/pages/en-gb/jobs).

## About The Job

[The successful candidate will have experience validating manufacturing

equipment and PLC and Computer-Based control

systems.]{contrast="none"}[]{contrast="none"}[Perform and document

instrument calibration and validation activities on a variety of

pharmaceutical manufacturing equipment and troubleshooting and repair

and, process validation i.e., media fills and stability

studies.]{contrast="none"}

**[Key Responsibilities]{contrast="auto"}**

• [Prepare, execute and summarize validation protocols and
  
  

reports.]{contrast="none"}[]{contrast="none"}

• [Proficiency with the Kaye AVS Validator (Programming, Operating,
  
  

Setup etc.]{contrast="none"}[]{contrast="none"}

• [Able to read and understand equipment PI&Ds, Electrical, Pneumatic
  
  

and arrangement drawings.]{contrast="none"}[]{contrast="none"}

• [Working knowledge of PC and PLC base control systems software and
  
  

hardware.]{contrast="none"}[]{contrast="none"}

• [Working knowledge of FDA and cGMP guidelines as related to
  
  

CVQ.]{contrast="none"}[]{contrast="none"}

• [Experience validating and qualifying, but not limited to Utilities,
  
  

Distillate Systems, Syringe, Vial and Eye Dropper Filling Machines,

Autoclaves, Glassware and Vial Washers, Stability Chambers Drug

Product Storage and Cleanrooms.]{contrast="none"}[]{contrast="none"}

• [Experience with PV and Stability
  
  

studies.]{contrast="none"}[]{contrast="none"}

• [Has the functional and technical knowledge and skills to do the job
  
  

at a high level of accomplishment.]{contrast="none"}

• [Uses rigorous and logic and methods to solve difficult problems
  
  

with effective solutions.]{contrast="none"}

• [Maintains a conscious balance between work and personal life as to
  
  

not allow one to dominate the other.]{contrast="none"}

## Basic Qualifications

• [BS degree in Mechanical, Industrial, Automation, or Chemical
  
  

Engineering. and/or equivalent experience in pharmaceutical related

discipline.]{contrast="none"}[]{contrast="none"}

• [3 to 5 years experiences in metrology and validation of
  
  

pharmaceutical manufacturing

equipment.]{contrast="none"}[]{contrast="none"}

• [Experience participating in regulatory inspections and
  
  

explaining/defending work.]{contrast="none"}[]{contrast="none"}

• [General knowledge of the injectable pharmaceutical industry,
  
  

sterile compounding preferred.]{contrast="none"}[]{contrast="none"}

• [Experience working in cGMP environments meeting FDA, EMA, ICH
  
  

guidelines, local regulations, and industry best

practices.]{contrast="none"}[]{contrast="none"}

• [Working knowledge of applicable GMP regulations, particularly 21
  
  

CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA

guidance on Data Integrity.]{contrast="none"}[]{contrast="none"}

• [Experience with aspects of pharmaceutical GMP regulations (e.g.
  
  

quality systems, root cause

analysis).]{contrast="none"}[]{contrast="none"}

• [Knowledge of GMP including international
  
  

regulations.]{contrast="none"}[]{contrast="none"}

• [Knowledge of applicable parts of 21 CFR Part 210, and 211
  
  

regulations and guidance.]{con rast="none"}[]{contrast="none"}

• [Ability to handle multiple and changing priorities and tight
  
  

deadlines while remaining

detail-oriented.]{contrast="none"}[]{contrast="none"}

• [Good verbal and written communication skills.]{contrast="none"}
  
  

## What\'s on Offer?