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Validation Engineer

Eliquent Life Sciences
Los Angeles, USA
Full Time, Part Time
Mid
Hybrid
USD 90000-110000 yearly / year
Discovered 1 months ago
IQOQPQValidation Master Plans (VMP)URSGxP

Full Job Posting

Key Responsibilities

  • Develop and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of Facilities, Utilities and Equipment (tanks/vessels, centrifuges, filter presses, etc.)
  • Coordinate and oversee the installation, testing, and validation of equipment and systems
  • Ensure compliance with regulatory guidelines (FDA, EMA, etc.) and industry standards (GMP, GxP)
  • Prepare and review validation documentation, including Validation Master Plans (VMP), User Requirement Specifications (URS), and risk assessments
  • Perform validation activities for processes, systems, and equipment, including writing and executing test plans and reports
  • Identify and resolve deviations and non-conformities, ensuring timely corrective actions
  • Communicate effectively with clients, project teams, and stakeholders to ensure project objectives are met.
  • Provide technical guidance and mentorship to junior team members.
  • Contribute to the development and implementation of best practices and standard operating procedures (SOPs) in CQV activities.
  • Stay current with industry trends, technological advancements, and regulatory changes

Requirements

  • BS in Engineering, Science or equivalent technical degree.
  • Solid understanding of GMP regulations and industry standards.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and collaboratively in a dynamic team environment.
  • Experience in commissioning, qualification, and validation within the pharmaceutical and/or medical device industry commensurate with the level of the project demand.
  • Strong analytical and problem-solving skills with attention to detail.
  • Understand and translate requestor's strategies into plans, and be able to drive the project to completion .

Benefits

  • What We Offer:
  • Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
  • Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
  • Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
  • Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.

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