Senior Specialist, QCAS Instrumentation

Bristol Myers Squibb; Leinster; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym access

Life assurance

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, QCAS Instrumentation to manage laboratory instrument qualification, calibration, installation and lifecycle maintenance in a GMP QC environment. The role reports to the QC Instrumentation Team Lead and requires strong coordination with QA validation and CSV colleagues.

Ideal candidates hold a B.Sc. in a science field with at least 3 years’ instrument qualification experience, including GMP-lab exposure.

Qualifications

• 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.
• Experience in data integrity management (21 CFR 11/EU Annex 11) is desirable.
• Strong understanding of instrument qualification procedures and lifecycle management in a biopharmaceutical GMP environment.

Responsibilities

• Provide calibration and/or maintenance service to the QC laboratory, including instrument calibrations and lifecycle management.
• Review and approve instrumentation qualification, calibration, repairs and documentation.
• Ensure instrument maintenance and verification are appropriate for instrument use.
• Manage instrument-specific investigations such as calibration deviations and trend analysis.
• Participate in new instrument purchase and qualification as part of QC team.

Skills

Instrument qualification

GMP experience

Project management

Communication skills

Education

B.Sc. in science-related field

Job description

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 will be part of a 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.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

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 workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in 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.

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R1607518 : Senior Specialist, QCAS Instrumentation