QC Instrument Engineer

PE Global; Dublin; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

PE Global is seeking a QC Shared Services Instrumentation Senior Specialist to execute Laboratory Instrumentation Purchase, Installation, Qualification and Lifecycle management in a GMP Dublin lab. The role is a 12-month contract with a hybrid work pattern.

The ideal candidate will have a B.Sc. in a scientific discipline and at least 3 years’ instrument qualification experience in a GMP setting, with data integrity familiarity.

Qualifications

• Minimum of a B.Sc. in a scientific discipline and at least 3 years of relevant experience, including instrument qualification in a GMP laboratory setting.
• Experience with instrument qualification documentation, calibration and lifecycle management is required or highly desirable.
• Knowledge of Data Integrity practices (21 CFR 11/EU Annex 11) is advantageous.

Responsibilities

• Provide calibration and/or maintenance service to the QC laboratory, including instrument calibration, maintenance scheduling and lifecycle management.
• Review and approve instrument qualification, calibration, repairs and documentation.
• Ensure instrument maintenance and verification aligns with instrument usage and lab requirements.
• Manage instrument investigations such as calibration deviations and trend performance.
• Contribute to instrument purchases and qualification activities and liaise with vendors and sister sites.
• Ensure compliance with corporate policies and current regulatory requirements for instrument qualification and lifecycle management.

Skills

Instrument management

GMP environment experience

Data Integrity (21 CFR 11/EU Annex 11)

Project planning

Team collaboration

Education

Bachelor's degree in scientific related discipline

Job description

PE Global is recruiting for a QC Instrument Engineer for a leading multinational biotech client based in Dublin. This is an initial 12-month contract, hybrid role.

Job Description:

Seeking to recruit a QC Shared Services Instrumentation Senior Specialist to execute Laboratory Instrumentation Purchase, Installation, Qualification and Lifecycle management. Reporting to the QC Instrumentation Team Lead, the specialist will manage the purchase and qualification of laboratory instruments and will be responsible for providing an Instrument Calibration and Maintenance service to the QC laboratory teams.

The candidate must have strong experience in all aspects of instrument management in a GMP environment, in addition to an understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories. They will have responsibility for establishment of project plans and instrument qualification procedures. Experience in Data Integrity management (21 CFR 11/EU Annex 11) is desired.

A strong fundamental understanding of protein biochemistry is desirable, in addition to technical expertise in the following Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, Liquid Handlers).

The main responsibilities for this position include;

• Providing a Calibration and/or Maintenance Service to the QC laboratory that includes instrumentation calibrations, scheduling and tracking of instrument maintenance and instrument lifecycle management.
• Review and approve analytical instrumentation qualification, calibration, repairs and documentation.
• Ensure instrument maintenance and verification is appropriate to the use of the instrument
• Manage all instrument specific investigations such as calibration deviations
• Trend lab instrument performance and lifecycle management.
• Participate in new instrument purchase and qualification
• Participate as part of a team of QC Specialists, QA validation Specialists and Computer System Validation personnel to deliver on the qualification of new instruments.
• Liaise with sister sites and vendors on instrumentation purchase, qualification and lifecycle management.
• Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management.
• Participate in definition and establishment of instrument related procedures.
• Participate in troubleshooting complex instrumentation issues.

The ideal candidate should hold a minimum of a B.Sc. in scientific related discipline and must have at least 3 year’s experience, at least 1 of which should be related to instrument qualification experience in a GMP laboratory setting. Previous experience in technology transfers would be advantageous.

The successful candidate must demonstrate the ability to contribute to and lead in a team based collaborative environment, as well as the ability to prioritise objectives from multiple projects. The successful candidate must demonstrate time management and organisational skills and excellent communication is essential.

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland