Biopharma IT Systems Compliance Engineer

Avid Bioservices

Tustin (CA)

On-site

USD 82,000 - 104,400

Full time

14 days+
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Benefits offered by this job

Health insurance
401(k) matching
Paid time off

Job summary

A leading biopharmaceutical company in California seeks an Engineer for IT Systems Compliance. This role involves validating manufacturing equipment and laboratory instruments within a cGMP environment. You will review specifications, generate validation protocols, and engage collaboratively with various departments. The ideal candidate holds a scientific or engineering degree, has over three years of relevant experience, and thrives in a detail-oriented team atmosphere. Compensation is competitive with opportunities for growth.

Qualifications

  • 3+ years experience in biopharmaceutical manufacturing.
  • 1+ year in validation directly.
  • Strong analytical skills.

Responsibilities

  • Review and author User Requirement Specification documents.
  • Generate and execute validation protocols.
  • Coordinate validation activities with departments.
  • Evaluate and analyze qualification data.
  • Document deviations and ensure compliance.
  • Develop validation policies and procedures.

Skills

Validation compliance expertise
Technical documentation
Cross-functional coordination
Detail-oriented
Strong communication skills

Education

BA/BS in science or engineering

Job description

A leading biopharmaceutical company in California seeks an Engineer for IT Systems Compliance. This role involves validating manufacturing equipment and laboratory instruments within a cGMP environment. You will review specifications, generate validation protocols, and engage collaboratively with various departments. The ideal candidate holds a scientific or engineering degree, has over three years of relevant experience, and thrives in a detail-oriented team atmosphere. Compensation is competitive with opportunities for growth.
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