CSV Engineer
Katalyst HealthCares & Life Sciences
Summary: 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 and Data Lake platforms, ensuring compliance with regulatory requirements and data integrity standards.Roles & Responsibilities:Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systemsSupport validation activities for ERP Master Data Governance processes, ensuring data accuracy, integrity, and compliancePerform validation of Data Lake platforms and associated system interfaces, including data ingestion, transformation, and reporting layersCollaborate with cross-functional teams (IT, QA, Business, Data Engineering) to define validation scope, risk assessments, and acceptance criteriaEnsure compliance with GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycleSupport deviation investigations, CAPAs, and change control activities related to validated systemsMaintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Summary ReportsEducation & Experience:Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences environmentsStrong experience with test script authoring and execution for GxP systemsExperience supporting Master Data Governance processes (SAP experience preferred but not required)Experience validating Data Lake environments and system interfaces (Snowflake experience preferred)Familiarity with AI/advanced data platforms is a plusExperience with validation management tools such as Val Genesis is a plusStrong understanding of GxP, 21 CFR Part 11, and data integrity principlesAbility to work independently and manage multiple validation activities with minimal oversight
- ...looking for a qualified candidate for a role focused on Technology Quality Manufacturing and MES Services. This position requires a strong CSV and Quality expertise for leading validation activities across the SDLC in GxP systems with a desire for 7-10 years of relevant...SuggestedRemote work
Raas Infotek
Raritan, NJ1 day ago - ...validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the...Suggested
- 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 scripts, validation documents Ensure...SuggestedRemote work
- 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, risk-based validation activities...Suggested
$86k - $121k
...interoperability.Handle the most complex enterprise integrations as well as IT and vendor relations.Enterprise Rollout & Validation (CSV)Partner with global quality business owners to author test scripts and drive Computer Systems Validation (CSV) or Computer Software Assurance...SuggestedHourly payLocal areaRelocation$200k - $250k
...solutions, and OneSource services.Job TitleVP, Project Controls Engineering - Project FarmaLocation(s)Bloomington, IN, Bloomington, IN,... ...Enterprise system integrations Validation Life Cycle (CQV, PV, CSV) Quality, Regulatory, and Compliance frameworks GxP automated systems...Full timeWork visa- Job DetailsDescriptionThe Automation Engineer is responsible for designing, implementing, and sustaining automated manufacturing systems that improve production efficiency, consistency, and cost performance. This role drives automation strategy by identifying capable vendors...Work at office
$93k - $110k
...re looking to apply your relevant experience to a new industry, join our team as we help shape a brighter way forward. Automation Engineer - JLL What this job involves: We are seeking an experienced Automation Engineer to design, develop, and implement automation control...Full timeApprenticeshipLocal areaRemote workShift workNight shift$76.12k - $96.42k
...from complex build to repeatable factory performance without losing precision, quality, or delivery speed. As a Manufacturing Engineer, you will turn production issues into durable process improvements for advanced electromechanical systems used in semiconductor manufacturing...Full timeFlexible hours$110k - $120k
...organizational, and communication skills, focused on supporting BEUMER’s installed systems within the Customer Support division. The Controls Engineer II applies professional programming knowledge to troubleshoot, optimize, and enhance machine control systems—primarily within...Daily paidFull timeLocal areaRemote workFlexible hours$90k - $125k
GFT is seeking an experienced Stormwater Engineer to join our Transportation Group in the tri-state (NY/NJ/CT) area. This role follows a hybrid work model, requiring regular attendance at one of our NYC, NJ, or CT offices. Working on the transportion teamat GFT offers...Full timeWork at officeRemote work$84.22k - $118.21k
...an Impact at Veeco - At Veeco, quality is a competitive advantage—and this role is at the center of how we scale it. As a Quality Engineer (QMS), you will drive the maturity, consistency, and effectiveness of our enterprise Quality Management System across multiple sites...Relocation package- ...and Biotech to name a few.Presently, our HORIBA Scientific OEM Division is searching for an experienced Electrical Hardware Design Engineer for our North American operation located in Piscataway, New Jersey. The ideal candidate will possess a strong electronics design...Temporary workWorldwideFlexible hours
$88k - $134k
...developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and... ...responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical...Flexible hoursNight shift- Company DescriptionBig Pharmaceutical OrganisationJob DescriptionAssociate Process Engineer/Scientist- Drug Product, Biologics Manufacturing Science and Technology Key responsibilities include• Execution of post-market process change activities/experiments through partnership...
- ...demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a...Work at officeLocal areaRemote workWorldwideFlexible hours
$128.56k - $162.84k
...equipment enables the world’s most advanced semiconductors, photonics, MEMS, and compound devices. Veeco is seeking a Senior Electrical Engineer to play a critical role in designing precision motion control, sensing, and embedded electronic systems that make these...Worldwide- ...demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a...Permanent employmentWork at officeLocal areaWorldwideFlexible hours
$205k - $236k
Description:The Director, Reliability Engineering, is responsible for providing tactical leadership and technical oversight for all site facilities maintenance aspects, utilities, automation systems, and equipment reliability across multiple pharmaceutical manufacturing...Temporary workFor contractorsLocal areaFlexible hours- Responsibilities: Develop and document assembly processes using Lean Manufacturing methodologies. This will include complete documentation of the sequence of operation, standard times, material layout quality checks and process documentation. Coordinate with...
- **About the Role:** As a CBRE Union Building Engineer, you will be responsible for monitoring, maintaining and repairing building system operations and the performance of various areas including plumbing, electrical, painting, roofing, heating, and cooling. This job is...Hourly payWork at officeLocal areaVisa sponsorshipFlexible hoursShift work
CBRE
New Brunswick, NJ4 days ago - ...our unique culture, visit our culture page.Essential Job Functions:The successful candidate will be responsible for manufacturing engineering work, including spectrometers with CCD or CMOS cameras, grating assemblies, light source alignment, and optical optimization, as...Temporary workWorldwideFlexible hours
$77.8k - $103.8k
Senior Quality Control (QC) Engineer – AI-Driven Testing & Validation Position Description CGI is seeking a forward-thinking Senior... ...activities comply with GxP regulations and Computer Software Validation (CSV) requirements. * Develop and maintain validation documentation...Work at officeLocal area$168.63k - $245.97k
...and lighting - have led the industry in performance and simplicity for over 40 years.OverviewThe Global Director of Manufacturing Engineering is a high-level position responsible for overseeing and leading the manufacturing engineering functions across multiple...Work experience placementWork at officeWorldwideFlexible hours$183k - $210k
Job DescriptionAt IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We...For contractorsWork at officeFlexible hoursNight shift- ...People who are knowledgeable, resourceful and mission driven. Together, we do great things.Who You Are: The Director of Electrical Engineering is a senior leadership role responsible for overseeing and managing electrical engineering design, standards, and execution...Full timeWork at office
$110k - $120k
...are proud of what our employees create each day. Integrity, Inspiration, Quality and Teamwork!Job DescriptionThe Mechanical Project Engineer is a hands-on role responsible for supporting, enhancing, and sustaining BEUMER’s installed material handling systems. This...Daily paidFull timeLocal areaFlexible hours- ...are proud of what our employees create each day. Integrity, Inspiration, Quality and Teamwork!Job DescriptionThe Mechanical Project Engineer is a hands-on individual with the maturity and experience to drive engineering projects from start to finish. This position...Daily paidFull timeLocal areaFlexible hours
$53 - $63 per hour
...and holistic quality oversight. · Partners with IT, business, CSV and vendor teams to apply risk-based approaches, maintain validated... ...· Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field preferred. · Minimum 7 years of experience...$115k - $125k
...hand. We are proud of what our employees create each day. Integrity, Inspiration, Quality and Teamwork!Job DescriptionThe Systems Engineer, based in Somerset, NJ, is a multifaceted role requiring an in-depth understanding of BEUMER sortation products and applications....Full timeLocal areaFlexible hours
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