Engineering Headhunters Los Angeles

Validation Specialist

techsupport 22 Aug 2022

Website Integress Inc

Location : Chino, CA

Position Summary

The validation specialist is responsible for all the calibration, change control of equipment/facility and validation activities related to IQ, OQ, PQ and PV. Ensure that validation protocols and reports are performed on timely basis and any equipment and facility used for manufacturing is maintained in a validated state to meet all GMP requirements and customer requirements.

A Technical Writer is responsible for producing high-quality documentation appropriate to its intended audience. This includes working with internal teams on product and document requirements, such as: SOP, Forms, Validation protocols & Reports, technical specifications, product architecture, manuals and process documentation.

Key Duties/Responsibilities

Tasks/ Responsibilities including but not limited to:

  • Responsible for the validation program (facility, equipment, process, cleaning)
  • Write and execute Validation protocols
  • Write the validation reports
  • Organize and run weekly meetings with team members and provide technical and statistical expertise based on production schedule and customer priorities
  • Facilitate implementation of process control systems and statistical process control charts
  • Researching topics, writing documents and editing internal policies, procedures and other form documentations and communicate with team members and customers
  • Exercise safety requirements
  • Maintain calibration program
  • Set department goals
  • Exercise and monitor GMP compliance in work environment
  • Leadership abilities with capacity to teach others
  • Support other areas of QA/QC as needed
  • Support all company policies
  • Provide technical and statistical expertise to teams
  • Understand and exercise all safety requirements and procedures

Skills and Abilities

  • Leadership
  • Communication Proficiency
  • Learning Orientation
  • Diversity and Inclusion
  • Presentation Skills
  • Time Management
  • Problem Solving/Analysis
  • Customer/Client Focus
  • Teamwork/Collaboration

Education and Experience

  • Bachelor’s Degree
  • 2+ year of related experience in Consumer Products
  • Excellent English written and verbal communication skills
  • Advanced mechanical, engineering and mathematical skills
  • Superior problem solving, decision making and organizational skills
  • Knowledge of GMP and validation required for drug manufacturing

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