Engineer - Lab Systems, Cell Therapy Devens
Bristol-Myers Squibb
Engineer - Lab Systems, Cell Therapy Devens
Job Description
Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as cellometers, plate readers, and flow cytometers throughout the site which include laboratory and manufacturing areas. Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support. Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems. Create , execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure. Execute and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders. Lead or provide supporting activities within the quality management system (Infinity) Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and performs system installations, configurations, administrative and support functions including system validation lifecycles and training. Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration. Provide digital plant subject matter expertise (SME), to multi-function teams, advises operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies. Ensure alignment with BMS directives and industry guidelines for applications. Execute on technology improvements and efficiency opportunities to improve business and compliance. Provide on-call support, as needed, for commercial operations. 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. BS degree in life sciences, engineering or computer field or equivalent experience. Minimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting. Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices. Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment. Demonstrated leadership skills and the ability to negotiate in a complex environment. Excellent verbal and written communication skills. The ability to plan and lead small and medium size projects and enhancements. Self-driven and capable of prioritizing. Have an expanding understanding of network, databases, servers, and PCs. Understanding of administration and usage of Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, ServiceNow and emerging technology is preferred. Ability to apply lean and OpEx principles.
About the Role/Company
- BMS organization with global partners
- Focus on compliance with industry guidelines and BMS directives
Key Responsibilities
- Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment
- Support various instrument types such as cellometers, plate readers, and flow cytometers throughout the site including laboratory and manufacturing areas
- Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support
- Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems
- Create, execute, and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure
- Execute and/or lead multiple projects and technical work assignments as a point of contact for project stakeholders
- Lead or provide supporting activities within the quality management system (Infinity)
- Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and perform system installations, configurations, administrative and support functions including system validation lifecycles and training
- Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration
- Provide digital plant subject matter expertise (SME) to multi-function teams, advise operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies
- Ensure alignment with BMS directives and industry guidelines for applications
- Execute on technology improvements and efficiency opportunities to improve business and compliance
- Provide on-call support, as needed, for commercial operations
Required Qualifications
- BS degree in life sciences, engineering, or computer field or equivalent experience
- Minimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices
- Familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting
- Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices
- Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU)
- Demonstrated leadership skills and the ability to negotiate in a complex environment
- Excellent verbal and written communication skills
- The ability to plan and lead small and medium size projects and enhancements
- Self-driven and capable of prioritizing
Preferred Qualifications
- Understanding of administration and usage of Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, ServiceNow and emerging technology
- Ability to apply lean and OpEx principles
Skills Required
- Expanding understanding of network, databases, servers, and PCs
- Ability to apply lean and OpEx principles
- Excellent verbal and written communication skills
- Demonstrated leadership skills and the ability to negotiate in a complex environment
- Self-driven and capable of prioritizing
Benefits & Perks
- 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
- Summer hours flexibility
Additional Requirements
- Provide on-call support, as needed, for commercial operations
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
100,000 - 150,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Expanding understanding of network, databases, servers, and PCsintermediate
- Ability to apply lean and OpEx principlesintermediate
- Excellent verbal and written communication skillsintermediate
- Demonstrated leadership skills and the ability to negotiate in a complex environmentintermediate
- Self-driven and capable of prioritizingintermediate
Required Qualifications
- BS degree in life sciences, engineering, or computer field or equivalent experience (experience)
- Minimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices (experience)
- Familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting (experience)
- Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices (experience)
- Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) (experience)
- Demonstrated leadership skills and the ability to negotiate in a complex environment (experience)
- Excellent verbal and written communication skills (experience)
- The ability to plan and lead small and medium size projects and enhancements (experience)
- Self-driven and capable of prioritizing (experience)
Preferred Qualifications
- Understanding of administration and usage of Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, ServiceNow and emerging technology (experience)
- Ability to apply lean and OpEx principles (experience)
Responsibilities
- Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment
- Support various instrument types such as cellometers, plate readers, and flow cytometers throughout the site including laboratory and manufacturing areas
- Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support
- Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems
- Create, execute, and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure
- Execute and/or lead multiple projects and technical work assignments as a point of contact for project stakeholders
- Lead or provide supporting activities within the quality management system (Infinity)
- Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and perform system installations, configurations, administrative and support functions including system validation lifecycles and training
- Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration
- Provide digital plant subject matter expertise (SME) to multi-function teams, advise operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies
- Ensure alignment with BMS directives and industry guidelines for applications
- Execute on technology improvements and efficiency opportunities to improve business and compliance
- Provide on-call support, as needed, for commercial operations
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Answer 10 quick questions to check your fit for Engineer - Lab Systems, Cell Therapy Devens @ Bristol-Myers Squibb.
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Engineer - Lab Systems, Cell Therapy Devens
Bristol-Myers Squibb
Engineer - Lab Systems, Cell Therapy Devens
Job Description
Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as cellometers, plate readers, and flow cytometers throughout the site which include laboratory and manufacturing areas. Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support. Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems. Create , execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure. Execute and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders. Lead or provide supporting activities within the quality management system (Infinity) Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and performs system installations, configurations, administrative and support functions including system validation lifecycles and training. Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration. Provide digital plant subject matter expertise (SME), to multi-function teams, advises operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies. Ensure alignment with BMS directives and industry guidelines for applications. Execute on technology improvements and efficiency opportunities to improve business and compliance. Provide on-call support, as needed, for commercial operations. 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. BS degree in life sciences, engineering or computer field or equivalent experience. Minimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting. Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices. Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment. Demonstrated leadership skills and the ability to negotiate in a complex environment. Excellent verbal and written communication skills. The ability to plan and lead small and medium size projects and enhancements. Self-driven and capable of prioritizing. Have an expanding understanding of network, databases, servers, and PCs. Understanding of administration and usage of Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, ServiceNow and emerging technology is preferred. Ability to apply lean and OpEx principles.
About the Role/Company
- BMS organization with global partners
- Focus on compliance with industry guidelines and BMS directives
Key Responsibilities
- Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment
- Support various instrument types such as cellometers, plate readers, and flow cytometers throughout the site including laboratory and manufacturing areas
- Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support
- Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems
- Create, execute, and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure
- Execute and/or lead multiple projects and technical work assignments as a point of contact for project stakeholders
- Lead or provide supporting activities within the quality management system (Infinity)
- Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and perform system installations, configurations, administrative and support functions including system validation lifecycles and training
- Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration
- Provide digital plant subject matter expertise (SME) to multi-function teams, advise operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies
- Ensure alignment with BMS directives and industry guidelines for applications
- Execute on technology improvements and efficiency opportunities to improve business and compliance
- Provide on-call support, as needed, for commercial operations
Required Qualifications
- BS degree in life sciences, engineering, or computer field or equivalent experience
- Minimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices
- Familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting
- Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices
- Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU)
- Demonstrated leadership skills and the ability to negotiate in a complex environment
- Excellent verbal and written communication skills
- The ability to plan and lead small and medium size projects and enhancements
- Self-driven and capable of prioritizing
Preferred Qualifications
- Understanding of administration and usage of Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, ServiceNow and emerging technology
- Ability to apply lean and OpEx principles
Skills Required
- Expanding understanding of network, databases, servers, and PCs
- Ability to apply lean and OpEx principles
- Excellent verbal and written communication skills
- Demonstrated leadership skills and the ability to negotiate in a complex environment
- Self-driven and capable of prioritizing
Benefits & Perks
- 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
- Summer hours flexibility
Additional Requirements
- Provide on-call support, as needed, for commercial operations
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
100,000 - 150,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Expanding understanding of network, databases, servers, and PCsintermediate
- Ability to apply lean and OpEx principlesintermediate
- Excellent verbal and written communication skillsintermediate
- Demonstrated leadership skills and the ability to negotiate in a complex environmentintermediate
- Self-driven and capable of prioritizingintermediate
Required Qualifications
- BS degree in life sciences, engineering, or computer field or equivalent experience (experience)
- Minimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices (experience)
- Familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting (experience)
- Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices (experience)
- Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) (experience)
- Demonstrated leadership skills and the ability to negotiate in a complex environment (experience)
- Excellent verbal and written communication skills (experience)
- The ability to plan and lead small and medium size projects and enhancements (experience)
- Self-driven and capable of prioritizing (experience)
Preferred Qualifications
- Understanding of administration and usage of Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, ServiceNow and emerging technology (experience)
- Ability to apply lean and OpEx principles (experience)
Responsibilities
- Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment
- Support various instrument types such as cellometers, plate readers, and flow cytometers throughout the site including laboratory and manufacturing areas
- Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support
- Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems
- Create, execute, and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure
- Execute and/or lead multiple projects and technical work assignments as a point of contact for project stakeholders
- Lead or provide supporting activities within the quality management system (Infinity)
- Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and perform system installations, configurations, administrative and support functions including system validation lifecycles and training
- Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration
- Provide digital plant subject matter expertise (SME) to multi-function teams, advise operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies
- Ensure alignment with BMS directives and industry guidelines for applications
- Execute on technology improvements and efficiency opportunities to improve business and compliance
- Provide on-call support, as needed, for commercial operations
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Engineer - Lab Systems, Cell Therapy Devens @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs