Maintenance Engineer, Sterile Drug Product Maintenance

at  BristolMyers Squibb

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 rich in diversity. 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 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 be tasked with initially supporting the facility during project phase, supporting equipment installation and commissioning - from initial specifications to final handover. Support will transition from project phase to operational phase to ensure a successful startup and commercialization of the facility, including GMP readiness and New Product Introductions.
The Maintenance teams will also focus on complying with good engineering practices, company policies, regulations, and codes.
The Maintenance Engineer will also support their manager in ensuring that the Drug Product Maintenance teams objectives are aligned with the wider Engineering and Site Objectives. They will be part of a multi-functional team charged with commissioning of the significant capital investment and upon completion of the project, they will support the sustaining operation on site.
This is a day’s role.

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.
• Working 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 optimize maintenance programs. Be an advocate for data visualization 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’s), 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.
• Qualifications & ExperienceRequired:
• 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 prioritizes safety, quality, and reliability in every task.
• Experience of maintenance optimization 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 organization 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.