Job Details

Validation Engineer II

  2025-09-13     Tailored Management     Vacaville,CA  
Description:

Job Title: Validation Engineer II
Location: 1000 New Horizons Way, Vacaville, CA 95688
Duration: 6-month contract (possibility of extension or conversion to permanent hire)
Schedule: Monday - Friday, 8:00 AM - 4:00 PM, fully onsite
Pay Rate: $37.38 - $62.29/hour (W2)
Benefits: Weekly pay, Medical, Dental, and Vision coverage

Position Overview
We are seeking a Validation Engineer II to support QC laboratory equipment qualification activities in compliance with cGMP regulations and Genentech/Roche standards. This role plays a critical part in ensuring operational readiness, regulatory compliance, and patient supply by executing validation protocols and contributing to continuous improvement initiatives. The ideal candidate brings strong technical skills, problem-solving ability, and a collaborative mindset.

Key Responsibilities

  • Perform qualification of laboratory equipment following established EQ policies, procedures, and plans.
  • Partner with laboratory staff to define equipment qualification requirements.
  • Author, review, and execute equipment qualification protocols.
  • Coordinate activities with vendors, contractors, and cross-functional support groups.
  • Identify gaps in business processes, quality, and compliance, and recommend improvements.
  • Ensure documentation accuracy and compliance by reviewing, signing, and approving records in line with company policies and procedures.
  • Support QC laboratory operations by assisting with other tasks as assigned by Senior Management.

Qualifications
  • Bachelor's degree in a scientific discipline preferred (e.g., Biology, Chemistry, Engineering).
  • Minimum of 2 years of validation or equipment qualification experience in the pharmaceutical or biopharmaceutical industry (or equivalent education/experience).
  • Strong knowledge of cGMP regulations and validation best practices.
  • Ability to prioritize, manage schedules, and make sound decisions under changing demands.
  • Flexible and adaptable with strong problem-solving and organizational skills.

Core Competencies
  • Strong verbal and written communication skills with the ability to influence at all levels.
  • Builds effective, trust-based relationships across teams.
  • Strategic thinker with ability to translate strategy into practical execution.
  • Results-driven with a strong sense of accountability and ownership.

Work Environment & Physical Requirements
  • Standard office and laboratory environment.
  • Ability to work safely and follow all site safety guidelines and quality standards.
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