Specialist, Maintenance Reliability Engineer II

Bristol Myers Squibb • Bothell, WA

2d • Onsite

About The Position

Execute the systems and asset lifecycle strategy, to ensure high reliability of assets, minimizing downtime and maximizing production capabilities. Asset induction and Preventive Maintenance administration and compliance in CMMS (BMRAM to MAXIMO)

Requirements

• Bachelor’s degree in engineering (Reliability or Mechanical preferred) or equivalent experience
• Minimum of five years' experience in reliability, ideally within the pharmaceutical sector.
• Understanding of current international regulatory regulations, cGxP requirements, and best practices, including 21 CFR part 11, 210, and 211, Annex 11, EU-GMP guidelines, and GAMP.
• Experience in Maintenance, Metrology, and CMMS management, preferably in the pharmaceutical sector.
• Experience with regulatory inspections.
• General knowledge of manufacturing, including Maintenance, Production, and Warehouse functions.
• Strong abilities in reporting and KPI tracking.
• 3+ yrs experience working in a GMP environment
• Solid understanding of business and GMP requirements.
• Proactive and action-oriented, with adaptability to change.
• Expertise in Data Management and a continuous improvement mindset.
• Ability to identify and communicate risks or priority conflicts promptly to keep deliverables on track.
• Able to build positive working relationships across departments.
• Strong negotiation, communication, and decision-making skills are highly desired.
• Good knowledge of Lean principles, including 5S and visual management.
• Critical thinking skills and a willingness to challenge the status quo.
• Demonstrates excellent team spirit and is an effective team player who can influence others within a matrixed organization.

Nice To Haves

• Strong knowledge of scheduling and planning is highly desired.
• Certificate in Reliability, Maintenance, or Reporting preferred

Responsibilities

• Develop, maintain, and ensure the accuracy and safety of job plans for maintenance execution in a bio-pharmaceutical manufacturing environment.
• Support the creation and modification of documentation such as Maximo Job Plans, Data Sheets, and Work Instructions.
• Apply operational excellence principles to maintenance activities, including cost-benefit analysis and the review or creation of metrics and KPIs related to maintenance execution.
• Collaborate with project engineering on small capital projects for equipment configuration changes.
• Identify and ensure availability of spare parts for routine maintenance and run-to-failure equipment.
• Support the MRO Storeroom in establishing stock levels and strategies, including critical spare parts requirements.
• Work with Asset Owners, Functional and Technical Users, and project teams to introduce new equipment, develop training for maintenance technicians, and create new maintenance strategies and job plans.
• Ensure necessary materials, parts, tools, and skill sets are available to complete tasks safely.
• Provide administrative support and supervision for cGMP asset compliance workflow in CMMS, including the PM program and asset criticality as defined by the Global Reliability Excellence Program, especially during the transition from BMRAM to Maximo over the next 24 months.
• Support the training of maintenance staff in new techniques, practices, and technologies.
• Review and approve documents such as work instructions, procedures, and training guidelines for technician training and work execution.
• Ensure the program meets compliance requirements by evaluating the Maintenance Program against relevant policies and regulations, supporting compliance investigations, CAPA, change control impact assessments, and health authority or internal audits.
• Ensure adherence to EHS guidelines, cGMP regulations, company policies, and external agency regulations.
• Support the development of procedures and programs to maintain compliance.
• Contributes to the development of planning and scheduling standards for major maintenance overhauls and outages, particularly during shutdown periods.
• Improve existing systems, practices, policies, and procedures related to maintenance and operations to enhance business performance and foster a culture of continuous improvement in reliability.
• Support the design and modification of systems to improve reliability, availability, maintainability, operability, safety, and life cycle costing, and participate in the development of design, installation specifications, and commissioning and qualification plans.
• Establish equipment criticality rankings and apply appropriate maintenance philosophies to develop robust systems lifecycle strategies.
• Monitor and analyze system failures to improve reliability and reduce life cycle costs.
• Help develop and generate key performance indicators to monitor and optimize systems lifecycle.
• Participate in Failure Mode and Effects Analysis (FMEA) and Reliability Centered Maintenance (RCM) exercises as a leader of departmental cross-functional teams.
• Support the development of the site’s asset investment plan (State of Good Repair) to ensure ongoing high equipment reliability while maintaining the lowest possible maintenance costs.
• Assist in compliance efforts related to Quality Events, CAPA, change management, and contamination investigations.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level