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Última actualización: hace 1 día
Manager Computer System Validation

Manager Computer System Validation

Bristol Myers SquibbSummit, NJ, US
A tiempo completo
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 optim...Mostrar másÚltima actualización: hace 1 día
Statistical Programmer II

Statistical Programmer II

cGxPServeJersey, NY, United States
A tiempo completo
Quick Apply
Job Description : Working with the Biometrics staff, the candidate will provide programming support for Phase 1 to Phase 3 studies. Providing timely support to the proj...Mostrar másÚltima actualización: hace 3 días
Statistical Programmer

Statistical Programmer

Katalyst Healthcares & Life SciencesRahway, NJ, US
A tiempo completo
Responsibilities : Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies. Provide statistical oversig...Mostrar másÚltima actualización: hace 2 días
Programmer Analyst I

Programmer Analyst I

PruTech SolutionsIselin, New Jersey
A tiempo completo
Design and implement client / server software solutions for the clients problems and use best practices of client / server software standards. Work on design and translate specifications into successful...Mostrar másÚltima actualización: hace más de 30 días
Remote Java Programmer

Remote Java Programmer

The Computer MerchantFlorham Park, NJ, US
Teletrabajo
A tiempo completo
Required Experience : Java / J2EE SQL and Relational Databases (e.Job Description : Work closely with other Support Developers, Maven Core Developers, and Quality Assurance Testing Engineers.Effectivel...Mostrar másÚltima actualización: hace 5 días
Programmer Analyst, Data

Programmer Analyst, Data

AudibleNewark, New Jersey
A tiempo completo
In this key role, you will be at the forefront of shaping and advancing our Data Engineering solutions, primarily through the enhancement of our existing data platform. Additionally, you will collab...Mostrar másÚltima actualización: hace más de 30 días
Application Programmer

Application Programmer

Genesis10Jersey City, NJ, US
Temporal
Genesis10 is currently seeking an Application Programmer with our client in the financial industry located in Jersey City, NJ. This is a 12+ month contract position.Responsibilities include design, ...Mostrar másÚltima actualización: hace 5 días
Programmer Analyst II

Programmer Analyst II

Audible, Inc.Newark, New Jersey, USA
A tiempo completo
Location : 33 Washington Street, Newark, NJ 07102.Duties : Utilize experience with business intelligence (BI) on cloud and on-premises to implement complex analytical solutions accessing data from mu...Mostrar másÚltima actualización: hace más de 30 días
CNC Programmer

CNC Programmer

Elgen StaffingSpringfield, New Jersey
A tiempo completo
Work directly with Manufacturing Manager, Machine Operators, Manufacturing Engineering, Design Engineering, and Production Control to produce good programs, keep machines running, and meet producti...Mostrar másÚltima actualización: hace más de 30 días
  • Oferta promocionada
Programmer Analyst

Programmer Analyst

VirtualVocationsElizabeth, New Jersey, United States
A tiempo completo
A company is looking for a Programmer Analyst (Remote).Key Responsibilities Develop and maintain PDF document output format and style functionality for eMOD Create and maintain XPP style and for...Mostrar másÚltima actualización: hace más de 30 días
Python Programmer

Python Programmer

SynergisticITJersey City, NJ, US
A tiempo completo
Synergistic IT is a full-service staffing and placement firm servicing clients in America for the past 12+ years.We are dedicated towards fulfilling the IT needs of our clients.From staffing to ful...Mostrar másÚltima actualización: hace 12 días
Senior Programmer / Analysts

Senior Programmer / Analysts

eTeamSecaucus, NJ, US
A tiempo completo
The Senior Programmer / Analyst's role is to define, develop, test, analyze, and maintain new software applications in support of the achievement of business requirements. This includes writing, codin...Mostrar másÚltima actualización: hace 3 días
Computer Systems Analyst

Computer Systems Analyst

TradeJobsWorkForce07032 Kearny, NJ, US
A tiempo completo
Training users on how to appropriately utilize their computer systems Writing instruction manuals for systems Consulting with managers to determine what role the systems play in the business Testin...Mostrar másÚltima actualización: hace 10 días
Statistical Programmer

Statistical Programmer

Katalyst HealthCares & Life SciencesNewark, NJ
A tiempo completo
Develop SAS programs and statistical output for the management and reporting of clinical trial data managed by GCD.Guarantee quality of statistical output produced by external provider, to program ...Mostrar másÚltima actualización: hace 23 días
Clinical Programmer IV

Clinical Programmer IV

GForce Life SciencesNew Jersey, US
Temporal
Our client, a global pharmaceutical organization, has engaged GForce Life Sciences to provide them with a Clinical Programmer. In this role, you will be responsible for assigned statistical programm...Mostrar másÚltima actualización: hace más de 30 días
Application Programmer

Application Programmer

NYC StaffingJersey City, NJ, US
Indefinido +1
Genesis10 is currently seeking an Application Programmer with our client in the financial industry located in Jersey City, NJ. This is a 12+ month contract position.Develop complex requirements, enh...Mostrar másÚltima actualización: hace 3 días
CNC Programmer

CNC Programmer

EquiliemKearny, NJ
A tiempo completo
CNC Programmer (Amada Punch & Laser).Responsibilities for CNC Programmer.Read technical drawings and set up the machines in accordance with these blueprints. Use computer software to program Punch a...Mostrar másÚltima actualización: hace más de 30 días
SDTM Programmer (SDTM, SAS)

SDTM Programmer (SDTM, SAS)

Tech DigitalRahway, NJ, US
A tiempo completo
Mandatory : SDTM, SAS Looking for 5+ years of clinical SAS programmers having in depth knowledge of CDISC SDTM.Gathering data from all available source and using SAS to process it.Preparing and pres...Mostrar másÚltima actualización: hace 5 días
Application Programmer V_Python

Application Programmer V_Python

InnovaJersey City, NJ, US
A tiempo completo
A client of Innova Solutions is immediately hiring for a.Mostrar másÚltima actualización: hace 1 día
ETL / PLSQL Programmer

ETL / PLSQL Programmer

Artech LLCJersey City, NJ
A tiempo completo
We are seeking a skilled and motivated individual to join our team as an ETL / PLSQL Programmer.The ideal candidate will have a strong technical and analytical background in developing complex ETL wo...Mostrar másÚltima actualización: hace 8 días
Manager Computer System Validation

Manager Computer System Validation

Bristol Myers SquibbSummit, NJ, US
Hace 1 día
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

locations

Summit West - NJ - US

time type

Full time

posted on

Posted Yesterday

job requisition id

R1592300

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. 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 .

About the Role

This position will drive computer system validation activities for the Summit site Manufacturing Execution Systems (MES) supporting the Summit, NJ Cell Therapy manufacturing site. This role is ideal for someone with a strong IT / Computer Science foundation and 5 years or more of hands-on experience in the pharma / biotech industry. You'll partner with other cross-functional teams such as QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions and support.

Key Responsibilities

  • Lead end-to-end validation activities including test preparation, authoring of IQ / System / UAT scripts, Dry Run, test data setup, environment readiness, test execution facilitation, and post-execution review.
  • Coordinate recipe configuration, master data setup, and validation in Syncade MES.
  • 3+ years of experience with Emerson Syncade MES, including knowledge of recipes, equipment and material management, and MES implementations in the pharmaceutical area.
  • Author, Review and Approve validation documentation lifecycle : Validation & Test Plan, requirement, Test Scripts, Assessment documents, and Summary Reports.
  • Validate electronic batch records (EBR), MES recipes, interfaces, and integration with systems such as SAP, Oracle, LIMS, CMMS, GPS, and EDMS.
  • Ensure all activities comply with 21 CFR Part 11, GAMP 5, and internal SOPs.
  • Strong project management skills (organization, collaboration, multi-tasking and communication), high degree of attention to detail, and the ability to perform well in a team-based environment are required.
  • Provide assistance as needed to support Health Authority inspections and internal audits.
  • Assist with investigations, triage deviations, and ensure CAPAs are addressed and implemented for MES.
  • Assist with program metrics by developing applicable tools and trackers, generating and analyzing quality system data for trending, performance deficiencies, and conformance to KPIs. Develops appropriate action plans as needed to remediate or continually improve on quality system performance.
  • Collaborate with Business Owners, QA, and IT to align on requirements and ensure CSV deliverables are compliant and audit ready.
  • Ensure validation practices meet GAMP 5, CSA, 21 CFR Part 11, and ALCOA+ data integrity principles.

Required Competencies

  • Proven ability to manage competing priorities with a flexible workstyle and consistently deliver efficient, compliant results in fast-paced, cross-functional environments.
  • Experienced in cross-functional communication, with the ability to interpret and convey business and IT needs for Validation; comfortable interacting with QA, business, and technical teams.
  • Understanding of MES Syncade & Recipes testing phases (IQ, System Testing, Recipe UAT).
  • Familiarity with cGMP, GAMP, SDLC, 21 CFR Part 11, and Good Documentation Practices (GDP).
  • Demonstrated ability to independently lead system validation efforts across multiple stakeholder groups.
  • Basic Qualifications

  • Bachelor's degree in Computer Science, Information Systems, or a related engineering discipline.
  • Minimum 5 years of experience or more in pharma / biotech, with focus on IT -Validation and Quality Assurance & Compliance
  • Experience with MES platforms (Syncade preferred) and electronic batch records (EBR).
  • Familiar with tools such as ALM, ServiceNow, SQL databases, and document management systems.
  • Knowledge of shop floor operations, process automation, and manufacturing environments are preferable
  • 5+ years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments, with strong knowledge of GAMP 5, 21 CFR Part 11, and Computer Software Assurance (CSA) principles.
  • 3+ years of hands-on MES experience with Emerson Syncade, including recipe validation, EBR testing, and interface verification with systems such as SAP, LIMS, and Oracle.
  • Experience with project management, demonstrating the ability to prioritize urgent tasks, manage competing deadlines, and adapt effectively within dynamic, cross-functional teams.
  • Experience with ALM, ServiceNow, SQL databases, and document management systems (e.g., Veeva, BMSDocs), supporting testing, issue tracking, and controlled documentation.
  • The starting compensation for this job is a range from $ 90,440- $109,600 , plus incentive cash and stock opportunities (based on eligibility).

    The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

    Final, individual compensation will be decided based on demonstrated experience.

    Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https : / / careers.bms.com / life-at-bms / .

    Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility / infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

    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 a supportive culture, promoting global participation 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 an 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.

    If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information : https : / / careers.bms.com / california-residents /

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.