Systems Engineer
3B Staffing LLC
Job Title : GxP Instrument Systems Engineer
Location: Norwood, MA
LOCATION
On-site 3-4 days/week between Marlborough, MA and Norwood, MA
Skills: Data Science, Data Warehouse
Job Description The qualified GxP Instrument Systems Engineer / Senior Project Engineer will be responsible for the design, deployment and management of automation and digital enterprise instrumentation systems that support Quality Control laboratories and system integration with connected Digital platforms.
JOB RESPONSIBILITIES
Collaborate with Business Analysts and Software/Automation Engineers in the complete product lifecycle management of Digital Quality Automation Systems (Hamilton Venus, Waters Andrew+ with OneLab, etc.) and Enterprise Instrumentation Systems (Chromeleon Chromatography Data System, Scientific Data Management System (LogiLab), CFR Gateway (LogiLab), SoftMax Pro, MODA, etc.) including optimizations, support, maintenance updates and version upgrades
Translate system/equipment/data integration requirements from various teams into deployable Digital Laboratory System solutions
Manage change control for regulatory Digital documentation (SOPs, work instructions, etc.) required to demonstrate appropriate compliance
Partner with stakeholders to validate and integrate key systems into the connected instrument pipeline, future robotics/automation capabilities and AI initiatives
Identify opportunities to optimize current processes and implement upgraded solutions
Ensure GMP compliance in the design, delivery and maintenance of all systems
Maintain inspection readiness throughout the duration of the project
Participate in internal and external audits as required
REQUIREMENTS
Bachelor's degree or equivalent in science, engineering or computer science discipline
5 to 7+ years' experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a biopharmaceutical GMP environment
Direct experience with automation solutions such as Hamilton Venus
Experience working with advanced automated laboratory analytical systems such as Waters Andrew+, Oxford Nanopore, and Hamilton Venus liquid handlers
Experience with GAMP and GxP compliance regulation
Experience with data integrity regulations, instrument integration and laboratory digital workflow optimization
Experience with Digital systems hosted in the cloud and an understanding of connectivity between on-prem systems and SAAS/Cloud
Strong understanding of core laboratory systems, related processes, and quality management workflows
Ability to work independently and in a team setting, with the ability to effectively communicate cross-functionally
Ability to support multiple concurrent projects in a fast-paced environment
Strong interpersonal and relationship-building skills
Location: Norwood, MA
LOCATION
On-site 3-4 days/week between Marlborough, MA and Norwood, MA
Skills: Data Science, Data Warehouse
Job Description The qualified GxP Instrument Systems Engineer / Senior Project Engineer will be responsible for the design, deployment and management of automation and digital enterprise instrumentation systems that support Quality Control laboratories and system integration with connected Digital platforms.
JOB RESPONSIBILITIES
Collaborate with Business Analysts and Software/Automation Engineers in the complete product lifecycle management of Digital Quality Automation Systems (Hamilton Venus, Waters Andrew+ with OneLab, etc.) and Enterprise Instrumentation Systems (Chromeleon Chromatography Data System, Scientific Data Management System (LogiLab), CFR Gateway (LogiLab), SoftMax Pro, MODA, etc.) including optimizations, support, maintenance updates and version upgrades
Translate system/equipment/data integration requirements from various teams into deployable Digital Laboratory System solutions
Manage change control for regulatory Digital documentation (SOPs, work instructions, etc.) required to demonstrate appropriate compliance
Partner with stakeholders to validate and integrate key systems into the connected instrument pipeline, future robotics/automation capabilities and AI initiatives
Identify opportunities to optimize current processes and implement upgraded solutions
Ensure GMP compliance in the design, delivery and maintenance of all systems
Maintain inspection readiness throughout the duration of the project
Participate in internal and external audits as required
REQUIREMENTS
Bachelor's degree or equivalent in science, engineering or computer science discipline
5 to 7+ years' experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a biopharmaceutical GMP environment
Direct experience with automation solutions such as Hamilton Venus
Experience working with advanced automated laboratory analytical systems such as Waters Andrew+, Oxford Nanopore, and Hamilton Venus liquid handlers
Experience with GAMP and GxP compliance regulation
Experience with data integrity regulations, instrument integration and laboratory digital workflow optimization
Experience with Digital systems hosted in the cloud and an understanding of connectivity between on-prem systems and SAAS/Cloud
Strong understanding of core laboratory systems, related processes, and quality management workflows
Ability to work independently and in a team setting, with the ability to effectively communicate cross-functionally
Ability to support multiple concurrent projects in a fast-paced environment
Strong interpersonal and relationship-building skills
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Systems Engineer in Norwood, MA vacancy
$130.73k - $137.5k
Basic Qualifications Requires a Bachelor’s degree in Systems Engineering, or a related Science, Engineering, Technology or Mathematics field. Also requires 5+ years of job-related experience, or a Master's degree plus 3 years of job-related experience. Agile experience...SuggestedFlexible hours$150.5k - $255.9k
...car would have made it into your hands without us. KLA invents systems and solutions for the manufacturing of wafers and reticles, integrated... ...15% of sales back into R&D. Our expert teams of physicists, engineers, data scientists and problem-solvers work together with the...SuggestedMinimum wageFull timeWork experience placementFlexible hours$130.37k - $144.63k
Basic Qualifications Requires a Bachelor’s degree in Systems Engineering, or a related Science, Engineering, Technology or Mathematics field. Also requires 5+ years of job-related experience, or a Master's degree plus 3 years of job-related experience. Agile experience...SuggestedFlexible hours$104.92k - $116.4k
Basic Qualifications Requires a Bachelor’s degree in Systems Engineering, or a related Science, Engineering, Technology or Mathematics field. Also requires 2+ years of job-related experience, or a Master's degree and 6 months of job-related experience. Agile experience...SuggestedSecond jobRemote workFlexible hours$164.89k - $173.91k
Basic Qualifications Requires a Bachelor’s degree in Systems Engineering, or a related Science, Engineering, Technology or Mathematics field. Also requires 8+ years of job-related experience, or a Master's degree plus 6 years of job-related experience. Agile experience...SuggestedRemote workFlexible hours$130.8k - $209.4k
...Basis administration, cloud operations, lifecycle management, system architecture, performance optimization, and security. This role... ...’s degree in computer science, Information Technology, Engineering, or related field.10-12 years of progressive SAP Basis Administration...Permanent employmentFull timeWork at officeWork from home$130.73k - $137.5k
...Systems Engineer As a Systems Engineer, working with custom software built in-house, for our Cyber group, you’ll be a member of a cross functional team responsible for developing mission critical NSA-certified Cybersecurity devices in a rapidly growing product line...Flexible hoursGeneral Dynamics
Dedham, MA5 days ago- ...JOB TITLE: Senior Systems Engineer JOB LOCATION: Dedham, MA WAGE RANGE*: 80-91 JOB NUMBER: 26-00966 JOB DESCRIPTION: Our client, a large defense contractor, has an immediate opening for a Senior Systems Engineer to work from their Dedham, MA facility. As...Hourly payTemporary workFor contractorsLocal areaImmediate startRemote workFlexible hours
The Computer Merchant
Dedham, MA1 day ago $100k
...it doesn't, production stops and deadlines slip. Nearly every system the business runs on touches infrastructure you're responsible... ...senior technical voice on the Infrastructure team, you're the engineer others turn to when they're stuck. The role mixes architecture...Hollingsworth ＆ Vose
East Walpole, MA1 day ago$192.11k - $202.62k
Basic Qualifications Bachelor's degree in Systems Engineering, or a related Science, Engineering or Mathematics field, plus a minimum of 10 years of relevant experience; or Master's degree, plus a minimum of 8 years of relevant experience.CLEARANCE REQUIREMENTS: Department...Flexible hours$130.8k - $209.4k
The RoleThe Candidae will report to and work closely with the Director, Digital LIMS Systems to ensure the implementation of new solutions and improvement of existing systems (LabVantage) for the Moderna Digital Laboratory Systems organization. This role will help shape...Permanent employmentFull timeWork experience placementWork at officeWork from home$164.89k - $176k
Basic Qualifications Bachelor's degree in Systems Engineering, or a related Science, Engineering or Mathematics field, plus a minimum of 8 years of relevant experience; or Master's degree, plus a minimum of 6 years of relevant experience.CLEARANCE REQUIREMENTS: Department...Flexible hours$149.9k - $166.3k
Basic Qualifications Bachelor's degree in Systems Engineering, or a related Science, Engineering or Mathematics field, plus a minimum of 8 years of relevant experience; or Master's degree, plus a minimum of 6 years of relevant experience.CLEARANCE REQUIREMENTS:Department...Flexible hours$68.9k - $131.1k
...growing fast and we want you to grow with us! We're expanding our engineering organization dramatically to meet exciting customer demand,... ...into reality? Do you thrive in dynamic environments? The Systems Engineering & Test Capabilities team discipline is seeking a Systems...Temporary workWork experience placementInterim roleWork at officeLocal areaRemote workRelocation packageFlexible hours$68.9k - $131.1k
...under this program/contract.Security Clearance Type: None/Not RequiredSecurity Clearance Status: Not RequiredOur Air Traffic Systems Engineering Department has an immediate opportunity for a Systems Engineer to join our ATS Air Traffic Control (ATC) team in Fullerton, CA...Contract workTemporary workWork experience placementStart working todayWork at officeImmediate startRemote workFlexible hours$146k - $194k
...companies to the defense industry, Anduril is changing how military systems are designed, built and sold. Anduril’s family of systems is... ....We are seeking a highly motivated and experienced Systems Engineer to join our Maritime team. You will work closely with the program...Full timeWork experience placementImmediate start$115k - $160k
...deeper understanding of their bodies and daily lives.WHOOP is building a deeply technical IT organization and is looking to add Systems Engineers. These are critical roles that will build the foundation for innovative, scalable IT operations. These roles will evolve our...Full timeWork at officeRelocation$110k - $150k
...deeper understanding of their bodies and daily lives.As a Battery Engineer II at WHOOP, you will help ensure the quality, reliability, and... ...the validation and development of next-generation battery systems through testing, failure analysis, supplier qualification, regulatory...Full timeWork at officeRelocation$68.9k - $131.1k
...toughest challenges and to meet the demands of a rapidly evolving global market. The Strategic Communications Team is seeking an Systems Engineer committed to creating creative and cost-effective solutions for our ground and airborne systems.As part of Collins Aerospace,...Temporary workWork experience placementWork at officeRemote workRelocation packageFlexible hours$68.9k - $131.1k
...job—it's embarking on a journey to shape the future of aerospace technology.Our Connected Aviation group is thrilled to offer a Systems Engineer II role within our Air Traffic Solutions (ATS) team in Marlborough, MA. As part of the ATS team, you'll be instrumental in...Contract workTemporary workWork experience placementStart working todayWork at officeRemote workWorldwideRelocationFlexible hours$86.8k - $165.2k
...this program/contract.Security Clearance Type: None/Not RequiredSecurity Clearance Status: Not RequiredOur Air Traffic Systems (ATS) Systems Engineering Department has an immediate opportunity for an experienced Systems Engineer to join our ATS Air Traffic Control (ATC)...Contract workTemporary workWork experience placementWork at officeImmediate startRemote workFlexible hours$165k - $195k
BostonEngineering - Systems Engineering /Full Time /HybridAbout Merlin: Merlin is a venture backed aerospace startup building a non-human pilot to enable both reduced crew and uncrewed flight. Backed by some of the world’s leading investors, Merlin is scaling alongside...Full time$165k - $220k
BostonEngineering - Systems Engineering /Full Time /HybridAbout Merlin: Merlin is a venture backed aerospace startup building a non-human pilot to enable both reduced crew and uncrewed flight. Backed by some of the world’s leading investors, Merlin is scaling alongside...Full time$86.8k - $165.2k
...the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today’s mission and stay ahead... ...secure world. Raytheon is seeking a talented and motivated Senior Systems Engineer to join our team within the Systems Engineering and...Temporary workWork experience placementWork at officeRemote workFlexible hours$137k - $235.75k
...Function: R&D Product DevelopmentJob Sub Function: R&D Software/Systems EngineeringJob Category:People LeaderAll Job Posting Locations... .... Learn more at We are hiring for Senior Navigation Systems Engineering Manager in a hybrid role to be based out of Raynham or Boston,...Full timeImmediate start$109.69k - $121.69k
Basic Qualifications Bachelor's degree in Systems Engineering, or a related Science, Engineering or Mathematics field, plus a minimum of 2 years of relevant experience; or Master's degree, plus 6 months of relevant experience.CLEARANCE REQUIREMENTS: Department of Defense...Work at officeFlexible hours$140k - $195k
...their bodies and daily lives, transforming the way they approach health and performance.WHOOP is seeking a highly skilled Senior Systems Engineer to join our Systems Engineering team within the hardware organization. This position bridges multiple disciplines—Electrical,...Full timeWork at officeRelocation$165k - $220k
BostonEngineering - Systems Engineering /Full Time /HybridAbout Merlin: Merlin is a venture backed aerospace startup building a non-human pilot to enable both reduced crew and uncrewed flight. Backed by some of the world’s leading investors, Merlin is scaling alongside...Full time$164.89k - $173.91k
...Systems Engineering Lead As a Lead Systems engineer for the Space, Cyber, and Intelligence business area, you’ll lead a cross functional team responsible for Crypto & Cross Domain Solution products, with an emphasis in leading systems development efforts for the Data...Flexible hoursGeneral Dynamics
Dedham, MA2 days ago$144k - $216k
...empower creators to own their own destiny.At Klaviyo, the IT Systems team builds and maintains the enterprise technology foundation... ...Klaviyos to do their best work. We are looking for a Senior Systems Engineering Manager, Corporate IT to lead and scale a high-impact...Temporary workWork at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Systems Engineer. Be the first to apply!
