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Specialist, Manufacturing Systems Validation, MS&T MSEO - Summit, United States - Bristol-Myers Squibb
Description
Specialist, Manufacturing Systems Validation, MS&T MSEO page is loadedSpecialist, Manufacturing Systems Validation, MS&T MSEO
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locations
Summit West - NJ - US
time type
Full time
posted on
Posted Yesterday
job requisition id
R
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:
.
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.
TheSpecialist
works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing.
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).
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.
BMSCART
VETERAN
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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 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 workplaceaccommodations/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
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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.#J-18808-Ljbffr
