Validation Team Lead Expert

3 days ago


Lakewood, New Jersey, United States Astrix Technology Full time
Astrix Technology seeks an experienced Validation Team Lead to manage validation activities for equipment, critical utilities, and facilities. This role is responsible for creating and approving qualification protocols, ensuring compliance with regulatory standards, and managing timelines.

This position requires a strong background in validation, with experience in aseptic pharmaceutical or biotech environments. The ideal candidate will have a Bachelor's degree in Science, Engineering, or a related field, and 5+ years of validation experience. Knowledge of FDA, GMP, ISO, EU, and ICH guidelines is also essential.

The estimated salary for this role is around $120,000 - $150,000 per year, depending on experience and qualifications. Benefits may include health insurance, retirement plans, and paid time off.

Key responsibilities include:
  1. Leading validation activities for equipment, utilities, and facilities
  2. Analyzing data to ensure processes meet regulatory standards
  3. Scheduling activities and managing resources to meet project deadlines
  4. Collaborating with clients on deliverables and timelines
  5. Supporting investigations and technical troubleshooting


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