CSV Engineer
United IT Solutions
Role - CSV Engineer
Location - Raritan, NJ(Hybrid)
Job Details:
• 5-10 years' experience in Computer System Validation of GxP systems
• Must have experience in Agile methodology and handled multiple releases in parallel
• Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation
• 5+ years of experience in validating SAP application implementation, test script review, test execution review, test defect management.
• Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA
• Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
• Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams
• Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report
• Must be familiar with procedures, work instructions, forms and templates
• Solid understanding of SDLC, Jira, QTest, automated test tools, code repository like bitbucket and change control/ management systems like ServiceNow
Location - Raritan, NJ(Hybrid)
Job Details:
• 5-10 years' experience in Computer System Validation of GxP systems
• Must have experience in Agile methodology and handled multiple releases in parallel
• Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation
• 5+ years of experience in validating SAP application implementation, test script review, test execution review, test defect management.
• Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA
• Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
• Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams
• Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report
• Must be familiar with procedures, work instructions, forms and templates
• Solid understanding of SDLC, Jira, QTest, automated test tools, code repository like bitbucket and change control/ management systems like ServiceNow
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the CSV Engineer in Raritan, NJ vacancy
- ...Independently support Business Separation activities for Large global & regional GxP Computerized systems. With minimal supervison. Strong CSV Expertise, especially within Acquisition/Divestiture/Separation. Ability to manage end-end from Inventory, assessments, remediations...SuggestedRemote work
Katalyst Healthcares & Life Sciences
Raritan, NJ4 days ago - Job-ID32263931Reference26-00597 Roles & Responsibilities Lead end-to-end CSV activities (inventory assessment remediation disposition) Support business separation for large GxP systems Define & implement risk-based validation strategies Review & approve test plans, UAT...SuggestedRemote work
Katalyst Healthcares & Life Sciences
Raritan, NJ6 days ago - Job-ID32293289Reference26-00631 Job Summary: Shop Floor CSV/CSA Lead/Engineer responsible for leading and executing validation deliverables across the lifecycle in regulated manufacturing and laboratory GMP/GLP environments. The role includes automation/controls validation...Suggested
Katalyst Healthcares & Life Sciences
Raritan, NJ6 days ago - ...delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology... ...how we can supercharge progress for you, visit Job Role - CSV Engineer Location - Raritan, NJ(Hybrid) Job Summary and Required...SuggestedRemote work
eTeam
Raritan, NJ1 day ago - Job-ID32200742Reference26-00496Summary: IT CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role will focus on validating ERP Master Data Governance processes...Suggested
Katalyst Healthcares & Life Sciences
Somerset, NJ5 days ago - Job Title Note - The resource must have experience in Microsoft Sharepoint and Power Platform tools, data analytics and dashboarding Job Description: • 8+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application...
Omni Inclusive
Raritan, NJ5 days ago - ...Testing (UAT, Regression Testing).Experience in leading application profile, operational requirements, and business process.7 years of CSV relevant experience.Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecycle in...
Katalyst Healthcares & Life Sciences
Raritan, NJ3 days ago - ...and risk assessments System & Industry Expertise Support CSV activities across various platforms including MES, DCS, SCADA,... ...and Experience Bachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted...Worldwide
CAI
Bridgewater, NJa month ago - ...Job Description Job Description Construction Project Engineer - Opened position with a dynamic and growing heavy construction company with a large backlog of work. Position is approximately 80% office-based and 20% field based. Role includes the following:...Work at office
Aspen Landscaping Contracting
Bridgewater, NJ20 days ago $180k - $250k
...enable Molex to serve the evolving needs of high-density, high-bandwidth, and flexible optical networks. The Senior Optical Alignment Engineer will lead the strategy and implementation of optical coupling of photonic components to laser diodes for advanced packages (e.g.,...Flexible hoursMolex
Bridgewater, NJ6 days ago- ...Acquisitions, Divestitures, and Business Separation projects Demonstrate strong leadership and stakeholder communication Experience: 7-10+ years of experience in Computer System Validation (CSV) Experience in Pharmaceutical / Biotechnology / Medical Device industry
Katalyst Healthcares & Life Sciences
Raritan, NJ4 days ago $150k - $190k
...Bridgewater, New JerseyCompany: MolexCareer Field: EngineeringJob Number: 190399Apply: JobWe are looking for an Optical Process Engineer to monitor, evaluate, and improve optical performance and manufacturability of our WSS products throughout their life cycle. In the...Flexible hoursMolex
Bridgewater, NJ4 days ago- ...demonstration of functional models. QualificationsQualifications: A BS degree in industrial automation, electrical or control systems engineering, information technology or relevant engineering discipline is required. A minimum of 10+ years of process control system...Work at officeLocal area
LanceSoft
Bridgewater, NJ3 days ago $36 - $43 per hour
...people’s health around the world. Together, we’re improving health and improving lives. Labcorp is seeking an On-Site Service Engineer to join our team. Location: Raritan, NJ Work Schedule: Monday through Friday, 11:00 PM to 7:30 AM (3rd Shift). Occasional...Hourly payPermanent employmentFull timeTemporary workCasual workInternshipH1bWork at officeMonday to FridayFlexible hoursShift workNight shiftWeekend workCovance Inc.
Raritan, NJ29 days ago- ...Labcorp seeks an On-Site Service Engineer for third-shift operations in Raritan, New Jersey, focused on installation, maintenance, and repair of laboratory automation systems. The role includes customer support, preventive maintenance, and troubleshooting of complex equipment...Permanent employmentWork at officeShift workNight shift
Labcorp
Raritan, NJ10 days ago - ...Civil Site Engineer – Land Development & Stormwater (0–5 Years Experience) We are looking for a Civil Site Engineer with 0–5 years of experience in land development and stormwater design to join our team. This role involves supporting the planning, design, and execution...InternshipLocal area
Liberty Personnel Services, Inc.
Bridgewater, NJ5 days ago $111k - $150k
...Service Automation Controls Engineer The Service Automation Controls Engineer is responsible for supporting, troubleshooting, and improving automation control solutions used in biopharmaceutical manufacturing and laboratory environments. This role provides technical...WorldwideFlexible hoursRepligen
Bridgewater, NJ1 day ago$31.73 - $42.31 per hour
...remote field-based position and with travel in central and northern New Jersey. How will you make an impact? IDD Field Service Engineers (FSEs) provide exceptional on-site service on highly complex and integrated systems within hospitals and commercial reference...Hourly payTemporary workWork at officeRemote workNight shiftThermo Fisher Scientific
Bridgewater, NJ1 day ago$88.4k - $92k
...Experience Required 2 years of work experience as an Assistant Divisional Engineer, Divisional Engineer, Construction Engineer, Civil Engineer I, Civil Engineer, or a related occupation required. Minimum Education Required Bachelor’s degree or foreign equivalent...Full timeWork experience placementShift workDay shiftJPCL Engineering
Hillsborough, NJ1 day ago- ...growth with tuition reimbursement to help advance your education and professional development.Summary of the RoleA Civil Project Engineer is responsible for managing the planning, design, and construction of a variety of civil engineering projects, ensuring delivery on...Work at officeImmediate startRemote workFlexible hours
Core States Group
Bridgewater, NJ3 days ago - ...Senior End User Services (EUS) Support Engineer – Executive Support Specialist Position Location: Bridgewater NJ Duration: 12 Months+ Overview The Senior End User Services (EUS) Support Engineer is a high-profile, Tier-3 technical leader responsible for the...Full timeImmediate startRemote workHome office
Digile
Bridgewater, NJ2 hours ago - ...Quality Systems and others as required. QualificationsEDUCATION and/or EXPERIENCE • At a minimum, a BA/BS degree (BA Business or BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science. • Proficient in the use of MS Excel, MS PowerPoint,...Temporary work
LanceSoft
Bridgewater, NJ7 days ago $51.48 per hour
...Raritan, NJ. No Third-Party, No Corp to Corp, No Sponsorship Now, Future or Current Temporary Authorization Title: Process Engineer (MSAT) Location Raritan, NJ Onsite (Mon-Fri, 40 hours) Contract Duration: 12 months, with likely extension Pay Rate: $5...Hourly payContract workTemporary workLocal areaSource One Technical Solutions
Raritan, NJ3 days ago- ...some of the most powerful facilities in the world — those that change people's lives. We are the leading provider of sustainable Engineering, Architecture, Construction and Consulting solutions to the global life sciences and food and beverage industries. Our employees...Work at office
CRB
Bridgewater, NJ4 days ago $80k - $120k
...advance in your career and make an impact at Henkel. What youll doHenkel Adhesives is seeking a customer-facing Field Application Engineer to support our Tissue & Towel business. This role is critical in delivering technical service, driving value and promoting sustainability...Minimum wageLocal areaFlexible hoursHenkel
Bridgewater, NJ3 days ago- ...Job Description: We are seeking a Senior Automation Engineer with deep expertise in PowerShell and cloud-native technologies to design and deliver scalable, enterprise automation solutions. This role focuses on building event-driven, API-integrated systems using...
Omni Inclusive
Raritan, NJ1 day ago $84.5k
...using defined practices to establish compliance with users and functional requirements. •Provides training for OT Systems Users/Engineers in new automation technologies and process control applications. •Diagnosing and troubleshooting OT System hardware, software, and...Temporary workLocal areaWeekend workAfternoon shiftAbbVie
Somerville, NJ2 days ago$98.5k - $144.5k
...strategy for continuous improvement of the Food Equipment Product LineSeek opportunities and implement standardization of equipment, engineering procedures, safety systems, drawing and BOM methodologyLiaise with Applications Development team to transition new products to...Full timeTemporary workMesser Group
Bridgewater, NJ5 days ago- ...DescriptionThis contractor position is based in North America, preferably in New Jersey or Philadelphia. Reporting to the Senior Principal Engineer & Analytics Leader, the Operations Research Engineer will be focusing on developing and deploying advanced mathematical models &...For contractorsWork at office
LanceSoft
Bridgewater, NJ3 days ago $105k - $125k
...Quality Engineer This position drives quality assurance for structural steel, industrial fabrication, and energy-sector work. The mandate is disciplined review of specifications, strict code compliance, detailed & precise documentation, and hands-on verification of...Permanent employmentLiberty Personnel Services, Inc.
Manville, NJ5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CSV Engineer. Be the first to apply!
