Validation Engineer/Los Angeles/$90k

Los Angeles  ‐ Onsite
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Description

We are looking for a Validation Engineer to join and exciting Biologics company located in Los Angeles, CA. This is a mid sized and rapidly growing company with an exciting commercial product! We need someone with a 4-year degree and at least 5 years of relative industry experience. Here are a few requirements and expectations for the position;

Responsibilities
  • The Validation Engineer is responsible for the execution and management of qualification activities for equipment, utilities and facilities on site.
  • Execution of qualification activities for Process Validation and Cleaning Validation.
  • Assists external qualification personnel with the execution of major project qualification activities which require the use of temporary external resources.
  • Ensure all company and Site Validation policies and procedures are adhered to.
  • Maintain Equipment Change Control and Calibration program and policies.
  • Lead the development of equipment, utilities and / or facility qualification protocols and ensures they are in line with Validation policies and guidance documents (Liaising with equipment manufacturers, internal and external project personnel to ensure successful qualification execution).
  • Seek and retain approval for qualification protocols from site User groups (who approve documents from a user group operations perspective) Quality (who approve documents from a quality / regulatory compliance standpoint)
  • Lead the execution of qualification protocols on facilities, utilities, equipment, process and cleaning as necessary.
  • Ensure all qualification, equipment change control and calibration documentation is maintained up to date at all times.

  • Direct experience with regulated environments (i.e. cGMP, OSHA, EPA, ISO) required.
  • Technical expertise in biotech unit operations, ability to handle multiple projects at one time.
  • Design experience or owners experience in manufacturing processes required.
  • Design experience or owners experience in utility systems including purified water, HVAC, cleanrooms, CIP, compressed air and clean/plants systems desired.
  • Working knowledge of processes in Ultrafiltration, separation, process vessels, filling and packaging required.
  • Strong leadership, organizational planning, and project management skills


We are looking for local candidates who can interview as soon as possible. If you are interested please respond with information to b.ross(@)realstaffing.com . Thank you for you interest!

To find out more about Real please visit www.realstaffing.com
Start date
05/2013
From
Real Staffing US
Published at
01.06.2013
Project ID:
544909
Contract type
Permanent
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