Specialist, Instrumentation Specialist (Standalone/Process Support Equipment)

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Position summary: BMS Cruiserath Biologics seeks to recruit permanent 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 responsibilities will include:

• 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.

• Management of Vendors working on site Including management of vendor RAMS (Risk Assessment/Method Statements).

• 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).

Requirements, Qualifications, Knowledge and Skills required include:

• 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.

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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.

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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.

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

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