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Bms logo

Manager, QC Instrumentation Technical Lead

Bms
Posted 3 hours ago
🇮🇪Ireland🏢Hybrid📁Engineering & Development
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Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Role BMS Cruiserath Biologics is seeking to recruit a Manager, QC Instrumentation Technical Lead. This is a Fixed-Term contract role. Position Summary The QC Instrumentation Technical Lead is responsible for providing technical leadership and oversight of the QC laboratory instrumentation programme to ensure analytical equipment remains qualified, calibrated, maintained, compliant, and available to support laboratory operations. The role serves as the technical subject matter expert for instrumentation lifecycle management, instrument qualification, calibration strategies, troubleshooting, and compliance activities. The Technical Lead is responsible for leading instrumentation investigations, CAPAs and change controls, supporting regulatory inspections, evaluating instrument capability for new methods and products, and ensuring laboratory instrumentation programmes remain aligned with regulatory, compendial and corporate requirements. The position also provides technical mentoring and guidance to instrumentation specialists and laboratory personnel while supporting continuous improvement and digital transformation initiatives across the QC organisation. Key Responsibilities Instrument Lifecycle & Qualification Lead the lifecycle management of QC analytical instrumentation, ensuring equipment remains qualified, calibrated, maintained, compliant, and available to support laboratory operations. Manage qualification activities for new and existing laboratory instruments, including installation, qualification, performance verification, periodic review, requalification, maintenance and retirement activities. Assess instrument capability, performance and suitability for analytical methods, new product introductions and evolving laboratory requirements. Compliance & Quality Systems Own instrumentation-related investigations, deviations, CAPAs and change controls, ensuring timely and eAective resolution of quality and compliance issues. Maintain inspection readiness of instrumentation programmes and associated qualification, calibration, maintenance and lifecycle documentation. Ensure instrumentation procedures, qualification activities and calibration strategies remain aligned with regulatory, compendial and corporate requirements. Technical Support & Continuous Improvement Serve as the technical SME for laboratory instrumentation, providing support for complex troubleshooting, laboratory investigations and operational challenges. Support laboratory systems and digital initiatives, including platforms such as CIMS/LIMS, Maximo, Valgeneis, LES, SmartQC and other QC electronic systems. Identify and implement opportunities to improve instrumentation reliability, compliance, eAiciency and operational performance. Inspection Readiness & Leadership Act as the instrumentation SME during regulatory inspections, audits and cross functional reviews, leading responses to instrumentation-related observations. Provide technical leadership, coaching and guidance to instrumentation specialists and laboratory personnel, fostering knowledge sharing and continuous development. Collaborate with site, network and global stakeholders to deliver instrumentation projects, implement best practices and support strategic laboratory initiatives Required Competencies The successful candidate will demonstrate: Strong technical expertise in analytical laboratory instrumentation. Comprehensive understanding of equipment qualification and lifecycle management principles. Strong knowledge of cGMP, FDA, EMA, ICH and data integrity requirements. Excellent investigation, root cause analysis and problem-solving skills. Strong project management and organisational capabilities. Effective verbal, written and technical communication skills. Ability to manage multiple priorities and deliver against challenging timelines. Experience influencing stakeholders and working within multidisciplinary teams. Strong leadership, coaching and mentoring capabilities. Proven ability to support and lead regulatory inspections. Commitment to continuous improvement, operational excellence and compliance. Education, Experience and Qualifications Essential Bachelor’s degree in Science, Engineering or a related technical discipline. Minimum 5 years’ experience within the biopharmaceutical, pharmaceutical or related regulated industry. Minimum 2 years’ experience supporting analytical laboratory instrumentation in a GMP environment. Experience managing instrument qualification, calibration and maintenance programmes. Experience leading investigations, CAPAs and change controls. Strong technical writing and documentation review experience. Demonstrated experience supporting regulatory inspections and audits. Preferred Experience with chromatography, spectroscopy and general analytical laboratory instrumentation. 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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym #LI-Hybrid If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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 [email protected] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected] . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1605292 : Manager, QC Instrumentation Technical Lead

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