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Sr. Specialist, MSEO Engineering and CSV

2 months ago

Summit, United States Bristol-Myers Squibb Full time
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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

The Senior Specialist, MSEO Engineering and CSV is responsible for the execution of validation activities and validation deliverables associated with the lifecycle management of Manufacturing Systems (computer systems) for the Summit West Manufacturing Cell Therapy site.

The Sr. Specialist is an individual contributor, working cross-functionally, to support validation activities and compliant delivery and operation of Manufacturing Systems used across clinical and commercial value streams in the manufacture of cell therapy products, including:
  • Labeling Solutions
  • Manufacturing Execution tools
  • Data acquisition and reporting systems
  • Manufacturing Execution Systems (Enterprise and legacy MES systems)
  • Validation process definition and Continuous Improvement
The position requires strong technical knowledge of Computer System Validation (CSV), Computer System Assurance (CSA), Data Integrity (ALCOA+), Manufacturing Execution Systems, project management skills, and stakeholder coordination.

The incumbent must be independent, goal-oriented, flexible, able to work efficiently across multiple projects, enthusiastic, and innovative, with an expert understanding of validation and critical thinking to support the needs of the Site Manufacturing teams.
  • Advanced time management skills, including prioritizing and managing expectations in a fast paced working environment.
  • Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object validation.
  • Operate effectively and with minimal supervision within a team or independently, performing projects and related duties.
  • Advanced critical reasoning and decision-making skills.
  • Ability to work independently and in cross-functional teams.
  • Ability to coach, develop, delegate, and motivate others.
  • Working knowledge of MS Office Applications.
  • Experience with MES infrastructure, HP ALM, Electronic Document Management Systems, Change Management Systems, and middleware Web Methods preferred.
Shifts Available:

Monday - Friday, Standard Business Hours
  • Times subject to change, flexibility required to potentially work outside of standard business hours to meet business needs
  • This is a hybrid position however requires flexibility to be on site as needed to meet business needs
Responsibilities:
  • Provide expertise for the Manufacturing Systems Computer System Validation team.
  • Responsible for maintaining the validated state of Site Manufacturing Systems to ensure global and site compliance with policies and standards.
  • Promotes and enforces BMS standard systems, policies, and procedures across the full range of managed systems.
  • Promotes an environment of continuous quality and improvement of processes, standards, and procedures.
  • Responsible for planning to ensure the highest level of support for the site.
  • Provides validation-related coaching and mentoring to maximize team effectiveness and cohesion.
  • Responsible for participating in developing, implementing, and maintaining site procedures and policies for Manufacturing Systems Validation, aligning with BSM CSV processes, and delivering and maintaining validated technologies suitable for commercial manufacturing.
  • Works closely with business stakeholders, Business and Process Owners, Site IT, Quality, etc.
  • to establish and maintain service level expectations across all functions and systems.
  • Works closely with business owners, IT, Quality, network, and global partners to implement site validation strategies aligned with BMS CSV and GAMP guidance.
  • Continuously integrates with the business to understand current business processes and to provide technical guidance that enables and supports plans and strategies.
  • Identify and capitalize on opportunities for continuous improvement.
  • Participates in internal audits and regulatory inspections as Manufacturing Systems Validation representative and assists in generating responses to audit/inspection observations (as assigned).
  • Collaborate across the BMS Cell Therapy Network.
  • Supports business and compliance objectives by supporting projects, systems lifecycle management, and technology service activities.
  • Supports daily operations and enhancements of validated site manufacturing systems.
  • Responsible for execution of assigned tasks and deliverables on time and with high quality.
  • Accountable for the creation, review, and approval of validation documentation, e.g.,
  • Validation Plans, Requirements, Specifications (Design, Functional, Configuration), Test Scripts (IQ/OQ/PQ/UAT), Summary Reports, Trace Matrices, Standard Operating Procedures, and others.
  • Responsible for coordinating User Acceptance Testing activities, e.g., training individuals as qualified UAT testers, scheduling UAT execution, defect management, and resolution.
  • Works closely with Project Managers to develop detailed Project Plans related to validation tasks and deliverables.
  • Anticipates and prioritizes activities that support quality, service, and cost-effectiveness based on a risk-based approach.
  • Responsible for leading Change Control creation through implementation as part of the Quality Management System (as assigned).
  • Employs a high level of understanding of validation to identify issues and risks that may put the site manufacturing systems at risk. Responsible for escalation and mitigation of such.
  • Performs other tasks as assigned.
Knowledge & Skills:
  • Advanced knowledge of Computer Systems Validation with an ability to author, review, and approve validation and verification deliverables in biotechnology/pharmaceutical or related industries.
  • Advanced knowledge of Data integrity, cGMP, GXP regulations, and industry best practices for GxP computerized systems (GAMP, CSA, ALCOA, etc.).
  • Advanced technical document writing.
Basic Requirements:
  • Bachelor's degree required in Computer Systems, Engineering, Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience.
  • Advanced degree preferred.
  • Minimum of 3+ years of relevant work experience required in CSV and MES for the biotechnology/pharmaceutical industry.
  • Cell Therapy experience preferred.
Working Conditions:
  • The incumbent will be required to work in an office environment, potentially requiring ergonomic considerations.
  • The incumbent will be required to work in a conference room environment for moderate periods.
  • The incumbent may be expected to work non-standard work hours, including weekends, to support high-priority project deadlines or emergency efforts impacting product delivery.
  • Occasional excursions to labs, production areas, or warehouses require some level of gowning.
  • Occasional domestic and international travel.


This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Some other duties and responsibilities are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

BMSCART

#LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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