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Astrazeneca2 days ago

Validation Associate

$69,312–$90,972 year

On-site · Hamilton, Ontario, Canada

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Enterprise

Job Summary

The Validation Associate, under the guidance of the Senior Validation Lead, will participate in facility qualification, equipment qualification, and computer systems validation (CSV/IQ-OQ-PQ). Responsibilities include developing/executing/ reviewing CSV protocols, qualification plans for equipment and cleanrooms, maintaining calibration/maintenance schedules, coordinating validation activities, ensuring data integrity and risk assessments, updating the Validation Master Plan, and ensuring adherence to regulatory guidelines and internal SOPs. Requires a Bachelor's degree in science or engineering with 2-3 years in a regulated pharmaceutical environment; must be on-site in Hamilton, ON. Strong collaboration, communication, and organizational skills are essential.

Required Qualifications

  • Bachelor's degree in science or engineering
  • 2-3 years of relevant experience in a regulated industry
  • Familiarity with validation and qualification requirements for sterile manufacturing in pharmaceutical environment
  • Experience in generation/execution of qualification protocols and validation plans
  • Familiar with regulatory guidance on validation, qualification, and sterile drug manufacturing
  • Excellent written, organizational and communication skills
  • On-site (Hamilton, ON)
  • Ability to work in fast-paced, rapidly changing environment
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$69k – $91k / yr

Validation Associate · Astrazeneca

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