Job Summary:
The Calibration Technician V plays a critical role in ensuring laboratory equipment accuracy and compliance at Morrisville NC. Reporting to the Manager Laboratory Operations this senior-level position independently manages calibration maintenance and repairs of laboratory instruments. The technician collaborates with internal teams and external vendors upholding strict regulatory standards in a fast-paced Pharma/Biotech environment.
Emphasis on Skills:
- Deep knowledge of calibration methodology instrumentation and regulatory requirements
- Strong experience in Pharma/Biotech industry GMP GLP and GxP environments
- Proven capability to investigate and resolve calibration failures CAPAs and deviations
- Ability to interpret technical drawings and manage documentation accurately
Key Responsibilities:
- Plan schedule and perform equipment calibration maintenance and repairs using CMMS
- Manage onsite vendors ensuring regulatory and training compliance
- Review and approve vendor calibration and maintenance documentation
- Initiate and support investigations for calibration failures and instrument issues
- Oversee induction of new equipment establishing calibration requirements and schedules
- Research equipment specifications and define calibration acceptance criteria
- Conduct thermal mapping studies for controlled environments
- Maintain update and generate SOPs and controlled documentation
- Review system documentation including user requirements and specifications
- Interface with laboratory staff QA CSV Facilities Engineering and IT teams
- Obtain technical data from vendors and service providers
- Document all activities and ensure data accuracy in CMMS
- Ensure compliance with USP NIST FDA GLP and GMP regulations
Recruiter Insights:
- Attractive contract role with a competitive bill rate
- Senior-level autonomy in a high-impact laboratory function
- Opportunity to work in a leading Pharma/Biotech environment at RTP
- Preferred qualifications offer expansion potential: CLIA/R&D experience Calibration Certification
- Collaborative multi-disciplinary team environment
Candidate Insights:
- Significant responsibility and independence in laboratory operations
- Exposure to cutting-edge Pharma/Biotech practices and regulatory standards
- Opportunity to work with latest analytical instrumentation and small-scale manufacturing equipment
- High visibility role interfacing with cross-functional teams
- Potential for professional growth through advanced skill development and certification
Job Summary: The Calibration Technician V plays a critical role in ensuring laboratory equipment accuracy and compliance at Morrisville NC. Reporting to the Manager Laboratory Operations this senior-level position independently manages calibration maintenance and repairs of laboratory instruments. T...
Job Summary:
The Calibration Technician V plays a critical role in ensuring laboratory equipment accuracy and compliance at Morrisville NC. Reporting to the Manager Laboratory Operations this senior-level position independently manages calibration maintenance and repairs of laboratory instruments. The technician collaborates with internal teams and external vendors upholding strict regulatory standards in a fast-paced Pharma/Biotech environment.
Emphasis on Skills:
- Deep knowledge of calibration methodology instrumentation and regulatory requirements
- Strong experience in Pharma/Biotech industry GMP GLP and GxP environments
- Proven capability to investigate and resolve calibration failures CAPAs and deviations
- Ability to interpret technical drawings and manage documentation accurately
Key Responsibilities:
- Plan schedule and perform equipment calibration maintenance and repairs using CMMS
- Manage onsite vendors ensuring regulatory and training compliance
- Review and approve vendor calibration and maintenance documentation
- Initiate and support investigations for calibration failures and instrument issues
- Oversee induction of new equipment establishing calibration requirements and schedules
- Research equipment specifications and define calibration acceptance criteria
- Conduct thermal mapping studies for controlled environments
- Maintain update and generate SOPs and controlled documentation
- Review system documentation including user requirements and specifications
- Interface with laboratory staff QA CSV Facilities Engineering and IT teams
- Obtain technical data from vendors and service providers
- Document all activities and ensure data accuracy in CMMS
- Ensure compliance with USP NIST FDA GLP and GMP regulations
Recruiter Insights:
- Attractive contract role with a competitive bill rate
- Senior-level autonomy in a high-impact laboratory function
- Opportunity to work in a leading Pharma/Biotech environment at RTP
- Preferred qualifications offer expansion potential: CLIA/R&D experience Calibration Certification
- Collaborative multi-disciplinary team environment
Candidate Insights:
- Significant responsibility and independence in laboratory operations
- Exposure to cutting-edge Pharma/Biotech practices and regulatory standards
- Opportunity to work with latest analytical instrumentation and small-scale manufacturing equipment
- High visibility role interfacing with cross-functional teams
- Potential for professional growth through advanced skill development and certification
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