Senior Specialist, QCAS Instrumentation

Bristol Myers Squibb; Fingal; Presencial; EUR 70 000 - 95 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym and life assurance

Resumo da oferta

Bristol Myers Squibb in Ireland is seeking a Senior Specialist, QCAS Instrumentation to manage purchase, installation, qualification and lifecycle management of laboratory instruments in a GMP setting.

The role involves calibrations, verification, and coordination with QC/QA validation teams, with a focus on data integrity and regulatory compliance. On-site work and a comprehensive benefits package are included.

Qualificações

• Requires a minimum of a B.Sc. in a scientific discipline.
• At least 3 years of experience, with at least 1 in instrument qualification in a GMP laboratory.
• Strong ability to lead in a team-based environment and prioritize multiple projects.

Responsabilidades

• Provide calibration and/or maintenance services for QC instruments; schedule and track maintenance and lifecycle management.
• Review and approve instrument qualification, calibration, repairs and documentation.
• Ensure instrument maintenance aligns with intended use and verify compliance.
• Manage instrument-specific investigations such as calibration deviations.
• Trend instrument performance and lifecycle management; participate in purchasing and qualification of new instruments.
• Collaborate with QC/QA/CSV teams and liaise with sister sites and vendors.
• Ensure compliance with policies and regulatory requirements for instrument qualification and lifecycle management.
• Develop instrument procedures and assist in troubleshooting complex issues.

Conhecimentos

Team collaboration

Time management

Communication

Formação académica

B.Sc. in scientific discipline

Descrição da oferta de emprego

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

The Role

Cruiserath Biologics are seeking to recruit a Senior Specialist, QCAS Instrumentation 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).

Key Duties and Responsibilities:

• 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.

Qualifications,Knowledge and Skills Required:

• The ideal candidate should hold a minimum of a B.Sc. in scientific related discipline and must have at least 3 years' 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 prioritize objectives from multiple projects.
• The successful candidate must demonstrate time management and organizational skills and excellent communication is essential.

Why you should apply:

• You will help patients in their fight against serious diseases
• You willbe part ofa company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.

#LI-Onsite

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607518 : Senior Specialist, QCAS Instrumentation