Senior Calibration Technician – GMP Biotech, Onsite RTP

Asklepios Biopharmaceutical Inc

Durham (NC)

Sur place

USD 90 000 - 120 000

Plein temps

Il y a 5 jours
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Résumé du poste

AskBio Inc. in RTP, NC is seeking a Sr. Calibration Technician to perform advanced calibration, testing, troubleshooting, and maintenance of precision instruments across manufacturing, QA, and research.

You will lead calibration activities, train technicians, ensure GMP/FDA compliance, develop procedures, and support audits in cleanroom and controlled environments. This onsite role reports to the Manager, Calibration and Instrumentation.

Qualifications

  • Minimum requirements include a degree with several years of related experience or a combination per the posting.
  • In-depth understanding of FDA 21 CFR Part 11, GMP/GxP, and ISO 17025 requirements.
  • Proficiency with calibration of critical lab and manufacturing equipment.

Responsabilités

  • Perform and oversee calibration of critical instruments to ensure accuracy and compliance.
  • Lead and train calibration technicians (Levels I and II).
  • Develop, validate, and update calibration procedures to align with USP/ICH guidelines.

Connaissances

Regulatory knowledge
Calibration principles
Metrology
GxP
Leadership
Troubleshooting

Formation

Bachelor’s degree in related field
Master’s degree in related field
High School diploma with 9+ years of related work experience

Outils

Blue Mountain
ProCal
Microsoft Office

Description du poste

AskBio Inc. in RTP, NC is seeking a Sr. Calibration Technician to perform advanced calibration, testing, troubleshooting, and maintenance of precision instruments across manufacturing, QA, and research.

You will lead calibration activities, train technicians, ensure GMP/FDA compliance, develop procedures, and support audits in cleanroom and controlled environments. This onsite role reports to the Manager, Calibration and Instrumentation.

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