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Senior Specialist, Instrumentation (standalone/process Support Equipment)

Maintain and qualify laboratory and process support equipment to ensure GMP compliance
Dublin
Senior
18 hours agoBe an early applicant
Bristol Myers Squibb

Bristol Myers Squibb

A global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for serious diseases.

29 Similar Jobs at Bristol Myers Squibb

Senior Specialist Instrumentation

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.

Bristol Myers Squibb Ireland has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company's first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company's growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded "Biopharma Company of the Year 2019" in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021.

The Role

BMS Cruiserath Biologics seeks to recruit on a permanent contract, Senior Specialist Instrumentation who will be responsible for maintaining laboratory, standalone and process support equipment in the Manufacturing, Laboratories and Warehouse/Cryogenics facilities. The Senior Specialist, Instrumentation will report to the Manager, Standalone & Process Support Equipment Maintenance. A fundamental understanding of instrumentation and equipment qualification is desirable. Experience managing Vendors in a GMP environment extremely beneficial. Knowledge of Biopharmaceutical analytical platforms such as high and ultra performance liquid chromatography would be helpful, but not essential for the role.

Key Duties and Responsibilities:

  • Responsible for the calibration and maintenance program of laboratory/benchtop instruments, CTU's, standalone assets and process support equipment in the following areas: MPCC (Multi-product Cell Culture) standalone test equipment/benchtop instruments and process support equipment. GMP and non-GMP Lab CTU's (controlled temperature units) Non-GMP Upstream and Downstream Material Science and Technology Labs as well as Process Analytics lab equipment. Warehouse and Cryogenics standalone equipment.
  • Working with Engineering Planners on scheduling and tracking of instrument maintenance and instrument lifecycle management.
  • Safe management of Vendors working on site including management of vendor RAMS (Risk Assessment/Method Statements) and permits.
  • Review and approve documentation associated with analytical instrumentation qualification, calibration, and repairs.
  • Responsible for work order management/compliance for all assets in scope.
  • Participate, as part of a team, to deliver on the qualification of new instruments.
  • Participate in and own internal Investigations and CAPA's.
  • Improvement and Optimization of Maximo PM's/Job Plans and Data Sheets.
  • Point of contact for projects and change controls associated with equipment in scope.
  • Participate in troubleshooting of complex instrumentation/equipment issues.
  • Leading Downtime (DT) and Failure Analysis exercises to ensure re-occurring failures are resolved, with support from other functions.
  • Ensuring compliance with all Safety and Environmental regulations, and compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management.
  • Participate in internal and external regulatory audits, as required.
  • Developing task specific Work Instructions (WI's) and Risk Assessments (RA's).

Qualifications, Knowledge, and Skills Required:

  • The ideal candidate will hold a minimum of a Level 7 qualification in an engineering-related field or a BSc in a scientific discipline, complemented by at least three years of experience in a relevant role within a regulated manufacturing environment. Prior experience with instrument qualification in a GMP laboratory setting is highly desirable.
  • A mechanical, electrical or calibration trade is desirable.
  • Working knowledge of Maximo or equivalent CMMS system.
  • High level of attention to detail and strong problem-solving abilities.
  • Right First Time (RFT) and Reliability Excellence mindset.
  • Excellent communication skills and the ability to work in a cross-functional collaborative environment.

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.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through scienceâ„¢", 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.

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 adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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Senior Specialist, Instrumentation (standalone/process Support Equipment)
Dublin
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About Bristol Myers Squibb
A global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for serious diseases.