Position Summary
BMS Cruiserath Biologics is seeking an experienced engineering professional to join the Drug Product maintenance team. Reporting to the Manager, Sterile Drug Product Maintenance, the Maintenance Engineer will assist in delivering a safe working environment and a reliable plant to ensure continuity of supply of medicines for our patients.
Key Responsibilities
Reporting to the Manager, Sterile Drug Product Maintenance to support delivery of an effective maintenance program.
Work with the project & CQV teams to facilitate delivery, validation, and safe operation of equipment associated with the Sterile Drug Product (SDP) plant.
Develop Standard Operating Procedures (SOPs), Work Instructions (WIs), Risk Assessments (RAs) etc. for the effective and safe completion of maintenance tasks.
Create job plans and preventive maintenance (PM) routines for SDP process equipment.
Ensure spare parts, tools, and other services are available when required for maintenance tasks.
Work closely with the maintenance team and engineering planner to schedule and oversee job assignments and lead site technicians or contractors as required.
Follow up on completed work to ensure work orders are closed to required standards.
Coordinate with engineering stores to ensure spare parts are available for all work orders.
Enhance and improve the Computerized Maintenance Management System (e.g., Maximo) and other site systems to ensure clear transfer of information between engineers and technicians.
Ensure compliance to all regulatory GMP, safety, and environmental requirements.
Lead root cause analysis exercises with support from other functions, investigating equipment failures and system downtime to implement corrective and preventive actions.
Own quality deviation investigations, change controls, and Safe IM investigations and ensure corrective and preventive actions are completed.
Support Reliability Excellence initiatives by participating in local and corporate programs.
Pursue and use new technologies and methodologies to improve overall effectiveness of maintenance programs.
Deliver ongoing continuous improvement to plant and processes for a high‑performing team.
Support other reliability‑driven tasks as assigned by line manager.
Support condition‑based maintenance methodology, investigate how data can optimize maintenance programs, and advocate for data visualization using Spotfire/Tableau.
Champion a safety culture within the maintenance team and perform Safety GEMBA walks at assigned intervals.
Collaborate with key stakeholders such as manufacturing operations, manufacturing planners, and EHS.
Drive and promote good manufacturing practices (GMP), good documentation practices (GDP), and adherence to SOPs across the team.
Assist the maintenance manager with other maintenance work as per business needs, including but not limited to development of training materials, vendor management, and other continuous improvement activities.
Participate in maintenance reliability initiatives such as continuous improvement projects, toolbox talks, predictive maintenance, failure codes, surface imperfection, gasket management, correct torquing, and spare parts.
Required Qualifications
Minimum Level 8 Engineering qualification or equivalent with at least 3 years’ experience in a regulated manufacturing environment.
Experience working with process equipment in biologics, drug product, pharma, chemical, or food manufacturing facility (desirable).
Prioritization of safety, quality, and reliability in every task.
Experience with maintenance optimization techniques.
Working knowledge of Maximo or equivalent CMMS system.
High attention to detail and strong problem‑solving abilities.
Excellent communication skills and ability to work in a cross‑functional team with all levels of the organization.
Commitment to developing self and others.
Flexibility and ability to work independently and remotely as required.
Desired Qualifications
Experience with a site start‑up and handover from CQV to sustaining operations from a maintenance perspective.
Maintenance experience in sterile fill finish.
Equal Employment Opportunity
Many of BMS’s legal statements and policies ensure employees with disabilities can excel, and BMS will consider qualified applicants with arrest and conviction records in accordance with applicable laws.
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