Senior Specialist, QCAS Instrumentation

Bristol Myers Squibb UK & Ireland; Leinster; On-site; EUR 60,000 - 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 UK & Ireland is seeking a Senior Specialist, QCAS Instrumentation at Cruiserath Biologics to manage instrument qualification, calibration, and lifecycle management in a GMP QC lab. Reporting to the QC Instrumentation Team Lead, you will oversee calibration services and liaise with vendors for instrument qualification and purchases.

The role emphasizes data integrity with a focus on maintaining rigorous instrument qualification procedures and contributing to project planning.

Qualifications

• B.Sc. in scientific related discipline with at least 3 years’ GMP lab instrument qualification experience.
• Ability to lead in a team-based collaborative environment and prioritize multiple projects.
• Strong communication and organizational skills.

Responsibilities

• Provide calibration and/or maintenance service to the QC laboratory, including scheduling and lifecycle management of instruments.
• Review and approve analytical instrumentation qualification, calibration, repairs and documentation.
• Ensure instrument maintenance and verification aligns with instrument use requirements.
• Lead instrument-specific investigations such as calibration deviations and trend analysis.
• Contribute to new instrument purchase and qualification and liaise with vendors.

Skills

Time management

Organization

Communication

Team leadership

Education

B.Sc. in scientific 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.

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.

Candidate Rights

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

For roles based in Los Angeles County only If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/.

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