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Validation Engineer

  • LocationCosta Mesa, CA 92626 - United States
  • Work TypeFull Time - Permanent
  • Positions1 Position
  • Published At:24 days ago


  • Job no: 37400
  • Categories: Maintenance/Engineering

Job Description

Our client, a leading pharmaceutical company, is looking for a Validation Engineer to join their team. If you have the required experience and are up for a challenge, this could be a great opportunity for you. Responsibilities include:

1) Establish validation standards, develop testing protocols, prepare equipment, document testing results and write final reports

2) Develop validation protocols in compliance with IQ, OQ and PQ requirements and industry guidelines as related to quality control and assurance manufacturing

3) Perform annual revalidation for steam sterilizers and dry heat sterilizers using kaye validation system

4) Develop new sterilization cycles, as needed

5) Perform periodic evaluation review of manufacturing and laboratory equipment

6) Maintain calibration record of equipment and calibrate equipment, as needed

7) Implement validation master plan for processes and equipment

8) Design and implement various protocols to validate and monitor the various quality control and assurance manufacturing activities and systems, such as water systems and air handling units

9) Perform various quality control duties and initiate appropriate documentation, as required

10) Assist in change control systems

11) Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products

12) Issue work orders to perform preventive, general and facility maintenance

13) Create new SOPs, as needed

14) Participate in audit activities, as needed

15) Compose reports and make adjustments to equipment and processes that require improvement.

16) Perform risk-based analysis and validate various part 11 systems

17) Perform other duties as assigned

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the pharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in validation engineering

This role is ideal for a qualified, energetic individual who possesses great attention to detail. So, if you’re looking for a rare and exciting opportunity in validation engineering and want to do it within a quality company, this could be the perfect role for you - please apply ASAP!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience

  • Published on 15 Apr 2021, 1:34 PM