Senior Manager, Global Calibration and Reliability Excellence Engineer
Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: February 14, 2021
Senior Manager, Global Calibration and Reliability Excellence
Engineer New Brunswick - NJ - US At Bristol Myers Squibb, we are
inspired by a single vision - transforming patients' lives through
science.--In oncology, hematology, immunology and cardiovascular
disease - and one of the most diverse and promising pipelines in
the industry - each of our passionate colleagues contribute to
innovations that drive meaningful change. We bring a human touch to
every treatment we pioneer. Join us and make a difference.
PRINCIPLE OBJECTIVE OF POSITION The purpose of this role is to
provide Calibration expertise, as Global Process Lead, in support
of Global Reliability Excellence Program, assisting Operations and
Facilities sites/stakeholders across the network. Accountable to
provide high-level oversight, set strategy for the processes and
decision making to optimize and maintain ongoing sustainability of
Quality Management System (QMS) - Calibration.-- Drive consistent
practices and utilization of asset management systems, providing a
standardized global approach to manage assets across BMS Operations
and Facilities network. Lead global strategic initiatives, aligned
with the overall business strategy, to achieve measurable
improvement in key Brand level and Site operational performance
objectives. Drive continuous improvement and innovation within a
global network, with both internal and industry best practices
working across the organizations in a Community of Practice (COP)
fashion with Subject Matter Experts (SME). MAJOR DUTIES AND
- Lead QMS - Calibration global processes ensuring they remain in
a state of control and are both effective and efficient and in
compliance with Global GxP requirements, BMS Global Quality
Standards, and BMS Quality Management System principles.
- Lead efforts to scope, plan and implement process/program
improvements including accountability for sutainable improvements,
such as process, procedures, systems and training material changes
among others; and use of appropriate change management and
- Develop, Deploy and Maintain Calibration global processes.
- Provide leadership, coaching, and training for COP including
both the technical processes and the behaviors necessary to
optimize process execution across operations and Facilities
- Support sites with internal and external cGMP audit
- Participate/lead regulatory surveillance and benchmarking
initiatives with peers externally to stay abreast of changes in
regulations that affect impacted processes and also to identify new
ways of working and evolving technologies in this space.
- Develop, Deploy and Implement Global Reliability Excellence
programs and initiatives, aligned with the BMS business
- Provide input to the business Continuity Management Plan,
anticipating reliability-related, and non-reliability related risks
that could adversely impact plant operation.
- Liase with Facilities and Operations teams, IT and Quality and
Compliance among other functional leaders to identify and empower
COPs'/Focus Teams' members.
- Maintains global expertise through ongoing training and
participation in industry forums. KNOWLEDGE / SKILL Education:
- Bachelor's degree in Engineering or other Biopharmaceutical
related field Experience / Knowledge Desired:
- Calibration experience (prefer 5+) in Advanced Therapy
Medicinal Products (ATMPs)/ Biologics/Pharmaceutical/R&D
projects and operations.
- Minimum of 5 years' calibration experience in a regulated
industry (i.e. GxP manufacturing / supply chain / research and
development) with a broad based understanding of Pharmaceutical
manufacturing and overall business processes, including 2 years
experience in a multisite or network role is a plus.
- Comprehension of Industry and Regulatory Authorities
Regulations related to Biopharmaceutical Facilities including FDA,
EMA, ANVISA, ISPE, etc.
- Working knowledge of relevant industry guidelines: ISO 9000,
ISO-13485 or ISO-17025
- Proficiency with CMMS or CMMS systems and Calibration
Management Program and their application to work management
- Experience with Lean Six Sigma and techniques desired.
- Excellent planning, organizing, analysis and problem solving
skills. Strong background and understanding in the planning and
execution of projects.
- Ability to work in a fast-paced environment, organized and able
to prioritize tasks to meet multiple deadlines.
- Demonstrated proficiency with standard Project Management tools
(MS Project, Excel, Visio, SharePoint, PowerPoint) and
- Proven ability working in a leading role supporting multi-level
/ cross functional teams to achieve common business goals.
- Excellent interpersonal, verbal and written communication
- Demonstrated experience in asset or system life cycle
reliability is required. WORKING CONDITIONS
- Describe exposure to any hazardous/disagreeable conditions in
the environment: None
- Travel required (describe nature and frequency): Up to 50%
- Overnight absences required: Yes SUPERVISION EXERCISED Around
the world, we are passionate about making an impact on the lives of
patients with serious diseases. Empowered to apply our individual
talents and diverse perspectives in an inclusive culture, our
shared values of passion, innovation, urgency, accountability,
inclusion and integrity bring out the highest potential of each of
our colleagues. 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. W e're creatinginnovative
medicines for patients fighting serious diseases. We're also
nurturing our own diverse team with inspiring work and challenging
career options. No matter the role, each one of us makes a
contribution. And that makes all the difference.
Keywords: Bristol-Myers Squibb, New Brunswick , Senior Manager, Global Calibration and Reliability Excellence Engineer, Executive , New Brunswick, New Jersey
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