Ref No.

VE - 2019

Location

US ~ Garnet Valley, PA

Validation Engineer

Company Overview

Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success.  With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.

People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.

 

The Role

The responsibility of the Validation Engineer will be to author/execute qualification documents for processing/analytical equipment and facilities related to the manufacturing of clinical/commercial oral solid dosage (OSD) forms.

Documentation includes, but is not limited to, the following:

  • Installation/Operational/Performance Qualification (IQ/OQ/PQ) Protocols
  • Computer System Validation (CSV) Deliverables
  • Protocol Deviation Reports
  • Applicable Summary Reports
  • Revalidation Analysis Reports

 

The Candidate

  • Required: Bachelor of Science (BS), or specialty degree/certification from a vocational institution.
  • Preferred: BS in Mechanical or Electrical Engineering
  • Required: Minimum of three (3) years of experience in generation/execution of qualification documentation in a regulated GxP environment.

Competencies

  • Required: Fluent in communications (verbal/written) in English
  • Required: High level of proficiency in the use of Microsoft Office Suite Applications (i.e. – Word, Excel, PowerPoint, and Outlook).
  • Desired: Functional knowledge and utilization of Veriteq/Vaisala DL2000 series data logging equipment/software.
  • Desired: Functional knowledge and utilization of Microsoft Visio and Microsoft Project.
  • Desired: Functional knowledge of how to read/understand electrical, pneumatic, and piping & instrumentation diagrams.

 

Job Demands

The job may involve the following:

  • Very high concentration of work
  • Working outside normal working hours, as needed
  • To remain knowledgeable in current regulatory and industry standard requirements as they relate to this job description.

 

Company benefits

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

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