Associate Director – Validation

Scorpion Therapeutics

California (MD)

On-site

USD 150,000 - 190,000

Full time

3 days ago
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Job summary

Scorpion Therapeutics is seeking an Associate Director of Validation within Facilities and Engineering to oversee site-wide validation programs supporting GMP compliance in a pharmaceutical setting.

You will lead validation strategies for facilities, equipment, and processes, manage lifecycle activities from commissioning to audits, and ensure rigorous documentation and system compliance across sites.

Qualifications

  • 10-12 years in validation management, engineering, or capital projects in regulated industries.
  • Extensive GMP, FDA knowledge.
  • Strong project management, analytical, and communication skills.

Responsibilities

  • establishing validation strategies aligned with cGMP
  • leading validation projects for facilities, equipment, and processes
  • ensuring documentation and system compliance
  • managing validation lifecycle activities from commissioning to qualification and validation audits

Skills

Project management
Analytical skills
Communication skills
Leadership

Education

Bachelor's in Engineering or related field

Job description

Role

Associate Director of Validation within Facilities and Engineering, overseeing site-wide validation programs supporting GMP compliance in a pharmaceutical setting.

Responsibilities

establishing validation strategies aligned with cGMP, leading validation projects for facilities, equipment, and processes, and ensuring documentation and system compliance; managing validation lifecycle activities from commissioning to qualification and validation audits.

Requirements

Bachelor's in Engineering or related field; 10-12 years in validation management, engineering, or capital projects in regulated industries, with extensive GMP, FDA knowledge, and experience leading complex validation programs; strong project management, analytical, and communication skills.

High-Value

pharmaceutical manufacturing, facility and equipment validation, cGMP compliance, validation lifecycle management, capital projects, and regulatory audits.

Work setup

involves office and on-site environments with occasional travel to various sites and possible after-hours work.

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