Operations Excellence Engineer II

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Operations Excellence Engineer II CAR -T is responsible for performing functions to apply techniques and principles that will improve the end to end operations and supply chain process that will deliver best in class safety, quality, productivity and cost across the ide-cel and liso-cel value streams. This position is intended for someone with organizational curiosity and will think beyond the current status quo. Using lean/six sigma techniques, the person in this role will drive improvements both individually and through cross functional teams for cell therapy products for both global clinical trials and commercial supply.

The Operations Excellence Engineer II will require knowledge and experience in conducting time studies, mapping value streams, and preparing estimates of labor and material costs associated with proposed changes as well as other process inputs to recommend changes that lead to improvements and work closely with stakeholders to, recommend, and /or execute improvements

Responsibilities include, but are not limited to, the following:

Evaluate and establish processes and systems with the goal of improving product quality, throughput/capacity reduce costs, and/or reduce lead-time and cycle times.

Establish key performance metrics to drive operational stability and predictability and create predictive analytics and models to achieve future desired operational capability and growth

Identifies required resources including personnel, tooling, equipment, facilities, work-in-process and production

Create and maintain capacity models, simulation models, and proactively drive capacity solutions

Establishes work measurement programs and analyzes work samples to develop labor standards

Analyzes work force utilization, facility layout, and operational data such as production costs, process flow, headcount and production schedules, to determine efficient utilization of worker and equipment

Support project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management

Recommends methods for improving efficiency and reducing waste of raw materials and utilities.

Design and facilitate workshops to understand current processes, conduct route cause analysis investigation, design future state and develop change plans

Conduct Gemba style process documentation and diagnostic activities

Collect, consolidate, and analyze data and information, present it in a format that brings information to life and therefore supports effective decision making

Work across all levels, from business leaders to front-line staff, to identify business impacts and support the development of change plans

Create and modify material to support knowledge transfer, implementation and training

Participate in team meetings and contribute to the development of Process Excellence tools and methods

Run internal projects (e.g. Project initiation, planning, scope, funding requests, approvals, execution and closeout)

Direct multidisciplinary project teams to ensure delivery of the project on time, on budget and to pre-defined quality level. Prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate progress, risks and status to project stakeholders and senior management

Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs

Sponsor and support the change initiatives and the implementation of process improvement initiatives

Foster strong inter-team relationships to achieve common project goals

Interface with operations and serve as Operations Excellence SME

Support monitoring, analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production

Provide investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements

Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)

Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities

Support inspection readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations

Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)

Interact with other teams including Validation, Development, Operations, QA and Regulatory

Support Senior Operations Excellence Manager in accomplishing productivity and financial goals with the cross-functional team

Support the tracking of team metrics and manage completion of objectives and projects

Participate in routine plant operating meetings

Leadership:

Promote a mindset of continuous improvement, problem solving, and prevention

Create an environment of teamwork, open communication, and a sense of urgency

Support the change agent in promoting flexibility, creativity, and accountability

Support organizational strategic goals and objectives that are linked to the overall company strategy

Drive strong collaboration within the plant and across the network

Build trust and effective relationships with peers and stakeholders

Deliver business results through timely and quality decision making and advice

Foster a culture of compliance and strong environmental, health, and safety performance

Skills/Knowledge Required :

Four-year Degree in Industrial Engineer/Manufacturing Engineer or related field

Successful and demonstrable track record delivering end-to-end (from conception to benefits realization) process improvement initiatives

Experience with application of Operational Excellence and Lean Manufacturing principles

Preferred Lean/Six Sigma Green Belt Certification from accredited institution (e.g. ASQ)

Experience with Project Management and Change Management principles

Knowledge of cGMP's and multi-national bio-pharmaceutical/cell therapy regulations

Experience working with external parties and/or leading cross-functional teams

Possess strong verbal/written communication skills and ability to influence at all levels

Ability to think strategically and to translate strategy into actions

Ability to prioritize and provide clear direction to team members in a highly dynamic environment

4 or more years of manufacturing support or related experience in the bio-pharmaceutical industry

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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1520258_EN

Updated: 2020-01-30 00:00:00.000 UTC

Location: Summit,New Jersey

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com