Senior Specialist, QC Instrumentation

Our client  is looking to hire a Senior Specialist in QC Shared Services Instrumentation to oversee the purchase, installation, qualification, and lifecycle management of laboratory instrumentation. Reporting to the QC Instrumentation Team Lead, the role will involve managing the acquisition and qualification of laboratory instruments while providing calibration and maintenance services to QC laboratory teams.

The ideal candidate should have extensive experience with instrument management in a GMP environment and a strong understanding of the requirements and best practices for routine biopharmaceutical drug product and drug substance laboratories. They will be responsible for developing project plans and instrument qualification procedures. Experience with Data Integrity management (21 CFR 11/EU Annex 11) is preferred.

A solid understanding of protein biochemistry is advantageous, along with technical expertise in the following biopharmaceutical analytical platforms: HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, and Liquid Handlers.

Key Responsibilities:

• Provide Calibration and Maintenance services to the QC laboratory, including instrumentation calibrations, scheduling, tracking maintenance, and managing the instrument lifecycle.
• Review and approve qualification, calibration, repairs, and associated documentation for analytical instruments.
• Ensure that instrument maintenance and verification are appropriate for the intended use.
• Manage instrument-specific investigations, such as calibration deviations.
• Track lab instrument performance and oversee lifecycle management.
• Contribute to the purchase and qualification of new instruments.
• Collaborate with QC Specialists, QA Validation Specialists, and Computer System Validation personnel to qualify new instruments.
• Coordinate with sister sites and vendors on instrumentation purchase, qualification, and lifecycle management.
• Ensure compliance with corporate policies and regulatory requirements for instrument qualification, calibration, and lifecycle management.
• Participate in the development and establishment of instrument-related procedures.
• Troubleshoot complex instrumentation issues as required.

Qualifications:

• A minimum of a B.Sc. in a scientific discipline.
• At least 3 years of experience, with at least 1 year related to instrument qualification in a GMP laboratory environment. Previous experience in technology transfers is a plus.
• Strong ability to work effectively in a team environment and lead collaborative projects.
• Proven skills in time management, organization, and the ability to prioritize multiple projects.
• Excellent communication skills are essential.

The successful candidate must demonstrate the ability to work efficiently in a fast-paced, team-based environment while ensuring compliance and excellence in instrumentation management.