QC Instrumentation Specialist

In this role, you will be responsible for the effective management, calibration, qualification, and maintenance of laboratory instrumentation across the site. You will ensure all activities are performed in compliance with cGMP, GLP, ICH guidelines, and Chanelle Quality Systems, while maintaining the integrity, reliability, and availability of laboratory equipment.

You will play a key role in supporting validation activities, ensuring data integrity, maintaining audit readiness, and driving continuous improvement across instrumentation processes. This position reports directly to the QA Manager.

Location: 5 days onsite at our laboratory in Amman, Jordan

As QC Instrumentation Specialist, your key responsibilities are as follows:

Instrumentation Calibration & Maintenance

• Coordinate and perform calibration, qualification, and preventive maintenance of laboratory instrumentation

• Review and verify daily calibration activities (e.g. balances, pH meters, Milli-Q systems)

• Oversee corrective maintenance activities and ensure timely resolution of instrumentation issues

• Prepare and manage annual calibration and maintenance schedules

• Request and manage spare parts required for instrument upkeep

Environmental Monitoring & Thermal Mapping

• Monitor and review daily temperature and environmental conditions across:

  • Freezers, refrigerators, stability chambers

  • Laboratory, storage, and server areas

• Review and trend temperature and humidity data from data loggers

• Coordinate and follow up on thermal mapping activities for:

  • Stability chambers

  • Refrigerators and freezers

Validation & Compliance

• Generate and execute validation documentation including:

  • Validation Master Plans

  • Protocols and reports

• Prepare and review key validation deliverables:

  • User Requirements Specifications (URS)

  • Design Reviews

  • SOPs

  • Traceability Matrices

  • Validation test protocols

• Coordinate and execute validation studies for laboratory instruments and computerized systems

• Perform periodic reviews of computerized systems in line with validation requirements

• Ensure all activities comply with cGMP, GLP, ICH, and data integrity (ALCOA++) standards

Vendor & Service Provider Management

• Liaise and coordinate with instrument suppliers for installation, calibration, and support

• Validate and audit external service providers to ensure compliance with Chanelle standards

• Ensure all vendor activities are completed accurately and in accordance with regulatory and company requirements

Documentation & Data Integrity

• Maintain and organize validation and calibration documentation archives

• Maintain a master list of instrument history including:

  • Maintenance activities

  • Deviations

  • Out-of-calibration events

• Ensure data integrity across all documentation, including external calibration reports

• Prepare and analyze quarterly trends for out-of-calibration events to support continuous improvement

Lifecycle & Continuous Improvement

• Develop and maintain preventive maintenance and calibration schedules for new instrumentation

• Support laboratory teams through training on new instrumentation

• Participate in continuous improvement initiatives to enhance instrumentation reliability and compliance

Skills & Competencies

• Strong knowledge of cGMP, GLP, and ICH regulatory requirements

• Proven expertise in:

  • Instrument qualification, calibration, and maintenance

  • Validation lifecycle and documentation

  • Laboratory instrumentation troubleshooting

• Strong understanding of data integrity principles (ALCOA++)

• Excellent organisational skills with the ability to prioritise workload effectively

• Strong analytical and problem-solving capability

• High attention to detail with a commitment to quality and compliance

• Effective communication skills, both written and verbal

• Proactive, flexible, and collaborative team player

• Ability to work independently in a fast-paced, regulated environment

Qualifications & Experience

• Bachelor’s degree in Engineering, Chemistry, or a related scientific discipline

• Minimum 5 years’ experience in instrumentation qualification, calibration, and maintenance within a regulated (pharmaceutical/biotech) environment

• Experience in validation of laboratory instruments and computerized systems

• Strong technical writing and documentation skills

• Proficiency in Microsoft Office (Word, Excel, PowerPoint)and relevant data systems

• Experience with LIMS implementation is desirable

• Willingness and ability to travel domestically and internationally, as and when required