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 for our colleagues and a reliable plant to ensure continuity of supply of medicines for our patients. The Maintenance Engineer will initially support the facility during project phase, supporting equipment installation and commissioning – from initial specifications to final handover – and later transition to operational phase to ensure a successful start‑up and commercialization of the facility, including GMP readiness and New Product Introductions. The team focuses on complying with good engineering practices, company policies, regulations, and codes. The Maintenance Engineer will also support the manager in ensuring that the Drug Product Maintenance team objectives are aligned with the wider Engineering and Site objectives.
Key Responsibilities
Reporting to the Manager, Sterile Drug Product Maintenance to support delivery of an effective maintenance program to ensure process equipment operates in a safe and reliable manner.
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 the SDP process equipment.
Ensure spare parts, tools, or 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.
Co‑ordination with Engineering Stores to ensure spare parts are available for all work orders.
Enhance and improve Computerized Maintenance Management System (i.e. Maximo) and other site systems to ensure clear transfer of information between Engineers and Technicians.
Ensuring compliance to all regulatory GMP, Safety and Environmental requirements.
Lead root cause analysis exercises with support from other functions. Investigate equipment failures and system downtime to find root cause and implement effective corrective and preventive actions.
Own quality deviation investigations, change controls and Safe IM investigations as required and ensure corrective and preventive actions are effectively 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 to investigate how data can optimise maintenance programmes. Be an advocate for data visualisation using Spotfire/Tableau.
Champion a safety culture within the Maintenance team. Perform Safety GEMBA walks at assigned intervals.
Ensure maintenance and calibration activities are executed in compliance with all Regulatory requirements including Quality (cGDP/GMP), EHS, Global Engineering procedures, as well as all Local Regulatory requirements.
Collaborate with key stakeholders such as Manufacturing Operations, Manufacturing Planners and EHS.
Driving and promoting Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and adherence with Standard Operating Procedures (SOPs) across the team.
Assist the Maintenance Manager with any other maintenance work as per the business needs, including but not limited to development of training materials, vendor management, and other continuous improvement activities.
Support and participate in maintenance reliability initiatives Continuous Improvement (CI) projects, Support Toolbox Talks, Predictive Maintenance, Failure Codes, Surface Imperfection, gasket management, correct torquing, spare parts, etc.
Required
The successful candidate must possess at minimum a Level 8 Engineering qualification or equivalent coupled with at least 3 years' experience in a relevant role in a regulated manufacturing environment.
Experience of working with process equipment in a biologics, drug product, pharma, chemical or food manufacturing facility is desirable.
It is essential that the Maintenance Engineer prioritises safety, quality and reliability in every task.
Experience of maintenance optimisation techniques.
Working knowledge of Maximo or equivalent CMMS system.
High level of attention to detail and strong problem‑solving abilities.
Excellent communication skills and the ability to work in a team, in a cross‑functional collaborative environment with all levels of the organisation as required.
Developing self and others.
Flexible and amenable to change with ability to work independently and remotely when required.
Desired
Experience with a site start‑up and handover from CQV to Sustaining Operations, from a maintenance perspective.
Maintenance experience in Sterile Fill Finish.
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 adastaffingsupport@bms.com. 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.
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