Specialist, Manufacturing Systems Validation, Ms&t - Summit, United States - Bristol-Myers Squibb

Bristol-Myers Squibb

Verified Company

Summit, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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.

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.

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 reciperelated 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 oncall 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, riskbased 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 mínimal 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 nonstandard work hours, including weekends, to support highpriority 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
LI-Hybrid

Uniquely Interesting Work, Life-changing Careers

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, si