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Bristol-Myers Squibb Summit, United StatesSpecialist, Manufacturing Systems Validation, MS&T MSEO page is loaded · Specialist, Manufacturing Systems Validation, MS&T MSEO · Apply · locations · Summit West - NJ - US · time type · Full time · posted on · Posted Yesterday · job requisition id · R · Working with U ...
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Bristol-Myers Squibb Summit, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those arent 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 ...
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Bristol-Myers Squibb Summit, United States**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 productio ...
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Bristol-Myers Squibb Summit, United States**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 productio ...
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Bristol-Myers Squibb Summit, United States**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 ...
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Bristol-Myers Squibb Summit, United StatesWorking 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 li ...
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Bristol-Myers Squibb Summit, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those arent 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 ...
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Bristol-Myers Squibb Summit, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those arent 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 ...
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Specialist, Manufacturing Systems Validation, MS&T MSEO - Summit, United States - Bristol-Myers Squibb
Description
Working with UsChallenging. 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:
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 Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing.
This role is primarily an individual contributor but will routinely support project and production works.The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle.
The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant BMS procedures, such as CSV SOP but no limited and applicable health authority regulations.
Responsibilities:
Review & approve S12 MES Next Gen related qualification & validation documentation.
Work with BO, MES IT, and QA to ensure that the site validation documentation is created, reviewed, and approved appropriately.
Assist BO & MES IT in installing updated recipes and E-MES quailed recipe-related components (e.g., Operations, Behaviors, Interfaces, Equipment Classes, Reports, etc.) to the S12 site and verifying compliance with CSV.Work with QA to ensure CSV validation deliverables are prepared without compliance issues.
Provide CSV & validation Production and Project support to S12 MES Next Gen.Complete all tasks required per the Change Management Process for S12 MES Next Gen SOP and in compliance with CSV and related SOPs.
Review the summary reports from testing/validation to ensure all issues are resolved and approved.Ensuring that risks and issues impacting the validation strategy are resolved and mitigated.
Assist UAT Test Script authoring, execution, and defects closure.
Support IQ Test Script authoring, reviewing, and pre & post approvals of execution and defects closure.
Author the verification/validation related documents (e.g., Validation/Test Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/UAT], Summary Reports, Trace Matrices, SOPs, but not limited).Maintain the documents/testing trackers to support the needs of the Leader team.
Knowledge & Skills:
Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation.
Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotation.
Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
Understanding the concept of Critical thinking for Computerized Systems.Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs).Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods.
With advanced technical document writing and time management skills, including ability to prioritize and manage expectations.Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties.
Basic Requirements:
Bachelor's degree.
Minimum of 2+ years relevant work experience.
Preferred Requirements:
Bachelor's degree in a life sciences, engineering or technology discipline preferred.
Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment.
An equivalent combination of education, experience and training may substitute.
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.
The incumbent may travel between company sites for training, meetings, or corporate events on occasion.Occasional excursions to labs, production areas, or warehouses require some level of gowning.
BMSCARTVETERAN#LI-HybridIf 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 CareersWith a single vision as inspiring as "Transforming patients' lives through scienceTM ", 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 ProtocolBMS 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 Visit 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
