Bristol Myers Squibb Global Calibration and Reliability Excellence Engineer in Devens, Massachusetts
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 RESPONSIBILITIES
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 communication principles.
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 sites.
Support sites with internal and external cGMP audit findings.
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 strategy.
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
- 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 processes.
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 templates.
Proven ability working in a leading role supporting multi-level / cross functional teams to achieve common business goals.
Excellent interpersonal, verbal and written communication skills.
Demonstrated experience in asset or system life cycle reliability is required.
- Describe exposure to any hazardous/disagreeable conditions in the environment:
- Travel required (describe nature and frequency):
Up to 50%
- Overnight absences required:
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.
Company: Bristol Myers Squibb
Req Number: R1534730
Updated: 2021-05-08 00:41:48.172 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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