Bristol Myers Squibb
Overview
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. Compensation and Benefits
The starting compensation for this job is a range from $90,440 - $109,600, plus incentive cash and stock opportunities (based on eligibility). Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary by 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 Medical, pharmacy, dental and vision care; wellbeing resources; 401(k); disability and life insurance; paid holidays; vacation; volunteer days; parental, caregiver, bereavement, and military leave; family care resources; 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. On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. The occupancy type is determined by the nature and responsibilities of your role. Site-essential roles require 100% onsite; site-by-design roles may be hybrid with at least 50% onsite; field-based/remote roles require travel and meetings as directed. BMS is dedicated to accessibility and reasonable accommodations. If you require accommodations in the recruitment process, contact adastaffingsupport@bms.com. See our Equal Employment Opportunity statement at careers.bms.com/eeo-accessibility. BMS encourages vaccination for Covid-19 and boosters where permitted by policy. Employment considerations may include applicable laws related to arrest and conviction records. For California residents, see https://careers.bms.com/california-residents/ for additional information.
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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. Compensation and Benefits
The starting compensation for this job is a range from $90,440 - $109,600, plus incentive cash and stock opportunities (based on eligibility). Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary by 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 Medical, pharmacy, dental and vision care; wellbeing resources; 401(k); disability and life insurance; paid holidays; vacation; volunteer days; parental, caregiver, bereavement, and military leave; family care resources; 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. On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. The occupancy type is determined by the nature and responsibilities of your role. Site-essential roles require 100% onsite; site-by-design roles may be hybrid with at least 50% onsite; field-based/remote roles require travel and meetings as directed. BMS is dedicated to accessibility and reasonable accommodations. If you require accommodations in the recruitment process, contact adastaffingsupport@bms.com. See our Equal Employment Opportunity statement at careers.bms.com/eeo-accessibility. BMS encourages vaccination for Covid-19 and boosters where permitted by policy. Employment considerations may include applicable laws related to arrest and conviction records. For California residents, see https://careers.bms.com/california-residents/ for additional information.
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