QC Instrument Engineer New

3 weeks ago

Dublin, Dublin City, Ireland CPL Full time
Job Summary:

The Senior Specialist is responsible for executing 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. Knowledge 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. Responsible for establishment of project plans and instrument qualification procedures.

Main responsibilities include:

- Providing a Calibration and 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.

Key Requirements:

- 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.
- 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).
- Experience in Data Integrity management (21 CFR 11/EU Annex 11) is desired.
- Demonstrative ability to contribute to and lead in a team based collaborative environment, as well as the ability to prioritize objectives from multiple projects.
- Must demonstrate time management and organizational skills and excellent communication is essential.

#LI-PC2

  • Qc Instrumentation Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Resources Full time

    Cpl in partnership with SK are looking to hire QC Instrumentation Analyst to join the team on a 12-month contract on their Swords Campus, North Dublin.ABOUT US? SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of the-art facilities in Korea, US, France and Ireland.We are part of SK Inc., a Korea company with...

  • QC Instrumentation Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Resources Full time

    Position: QC Instrumentation Analyst Location: Swords, Co. Dublin Contract: 12-Month Fixed Term About Us SK pharmteco is a global Contract Development and Manufacturing Organization (CDMO) with state-of-the-art facilities in Korea, the US, France, and Ireland. We are part of SK Inc., a Korean company with revenues of $99 billion in 2023. Our mission is to...

  • QC Instrument Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland LSC, Life Science Consultants Full time

    OverviewQC Instrument Specialist contract opportunity in Dublin with a biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines.If you have 3+ years of industrial experience and are ready for your next challenge, this could be the perfect project for you.ResponsibilitiesProviding a calibration and/or maintenance...

  • Qc Instrumentation Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Resources Full time

    Position: QC Instrumentation Analyst Location: Swords, Co.Dublin Contract: 12-Month Fixed Term About Us SK pharmteco is a global Contract Development and Manufacturing Organization (CDMO) with state-of-the-art facilities in Korea, the US, France, and Ireland.We are part of SK Inc., a Korean company with revenues of $99 billion in 2023.Our mission is to...

  • Qc Instrumentation Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Resources Full time

    Position: QC Instrumentation Analyst Location: Swords, Co.Dublin Contract: 12-Month Fixed Term About Us SK pharmteco is a global Contract Development and Manufacturing Organization (CDMO) with state-of-the-art facilities in Korea, the US, France, and Ireland.We are part of SK Inc., a Korean company with revenues of $99 billion in 2023.Our mission is to...

  • QC Instrumentation Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with SK are looking to hire QC Instrumentation Analyst to join the team on a 12-month contract on their Swords Campus, North Dublin.ABOUT US?SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korea company with...

  • QC Instrument Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Life Science Consultants (LSC) Full time

    LSC have a great contract opportunity for a QC Instrument Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 3+ years industrial experience and are ready for your next challenge,...

  • QC Senior Analyst New

    3 weeks ago

    Dublin, Dublin City, Ireland CPL Full time

    QC Senior AnalystLocation: Swords, Co. DublinAbout the company:SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korea company with revenues of $99 billion in 2023. Our mission is to 'produce and deliver life-changing therapies that...

  • Qc Microbiologist

    3 weeks ago

    Dublin, Dublin City, Ireland Astellas Pharma Europe Ltd Full time

    QC Microbiologist About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed.We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting...

  • Qc Bioanalytical Associate

    3 weeks ago

    Dublin, Dublin City, Ireland Pe Global (Uk) Full time

    OverviewPE Global is currently recruiting for an QC Instrumentation Specialist for a leading multi-national Pharma client based in South Dublin.This is a hybrid contract position.RoleResponsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities...