GXP Jobs in Connecticut

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Project Manager - Gxp

Oraapps Inc

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Remote

Contract

Job Title -Project Manager Gxp Location - Remote Contract Duration - 6+ Months Requirement: - 8+ years full lifecycle PM experience - Demonstrated PMLC/SDLC experience/success - Ability to quickly adapt to a maturing project environment - Ability to manage multiple concurrent priorities - MS Project and the ability to execute project plan is a must have MUST BE STRONG MS PROJECT - GXP & GMP Experience - Heavy experience required Plus: - GMP project experience, preferably as a PM - PMP certific
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Posted 1 day ago | Updated 18 hours ago

SAP Project Manager-Bio-Pharma

NexInfo Solutions, Inc.

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Remote

Contract, Third Party

About Nexinfo: NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges
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Posted 4 days ago

Business Analyst

NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil
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Posted 9 days ago | Updated 9 hours ago

Veeva Presales Consultant

NexInfo Solutions, Inc.

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Remote

Contract

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content
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Posted 32 days ago | Updated 11 hours ago

IT Project Manager - -Infrastructure

NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 335427 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a IT Project Manager -- Infrastructure to join their team.NTT DATA's Client is seeking an experienced and results-driven IT Project Manager - Infrastructure to support strategic infrastructure transformation and remediation progr
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Posted 20 hours ago | Updated 9 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 33 days ago | Updated 2 hours ago

Global IT Compliance Sr Specialist

Thermo Fisher Scientific

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Pennsylvania, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 20 days ago | Updated 2 hours ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated 9 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 23 days ago | Updated 2 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 60+ days ago | Updated 2 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 32 days ago | Updated 2 hours ago

compliance lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 1 day ago

Assoc. Director, PV Systems Reporting & Analytics

Sunrise Systems, Inc.

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Remote

Contract

Position Title: Assoc. Director, PV Systems Reporting & Analytics Job ID: 25-09090 Location: Remote Duration: 05 months on W2 Contract Top skills: Argus Safety application and drug safety domain knowledge, Computer Systems Validation & SDLC experienceStrong matrix management skills OBJECTIVE: Oversee and support tools used for the reporting and interactive analysis of data from the global pharmacovigilance (PV) databaseProvide technical and strategic input into the roadmap, planning, and imple
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Posted 24 days ago | Updated 19 hours ago

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

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Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical
Posted 43 days ago | Updated 2 hours ago

Manager, IT/Senior Systems Analyst

Thermo Fisher Scientific

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Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Manager, IT/Senior Systems Analyst HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Support Thermo Fisher's integration of Tracelink (Track and Trace Solution) and Thermo Fisher's downstream partners to ensure Thermo Fisher is compliant with Serialization and Track and Trace requirements and detailing the technical
Posted 35 days ago | Updated 2 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 2 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 21 days ago | Updated 2 hours ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

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Remote or Santa Monica, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 57 days ago | Updated 2 hours ago

Kinaxis Rapid Response Consultant

NexInfo Solutions, Inc.

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Remote or Foster City, California, USA

Contract, Third Party

Job Title: Kinaxis Rapid Response Consultant Location: Remote Job Type: Contract Job Summary: We are looking for a skilled Kinaxis Rapid Response Consultant to join our supply chain planning team. The ideal candidate will have hands-on experience with Kinaxis Rapid Response platform, and a strong understanding of supply chain processes including demand planning, supply planning, and scenario modeling.Key Responsibilities: Configure, develop, and deploy solutions using Kinaxis Rapid ResponseCol
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Posted 60+ days ago | Updated 11 hours ago

Pharmacovigilance Business Analyst

Cygnus Professionals

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Remote

Full-time

Position Title: Pharmacovigilance Business AnalystLocation: Remote Duration: 12 plus months contract or Fulltime Requirements: Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field.Minimum 10+ years of Business Analyst experience is required.Clinical Trial domain expertise, including Study Execution, Site Monitoring, Data Management, and Patient Safety.Exposure to Pharmacovigilance, and Quality and Compliance processes preferred.Experience with SQL and
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Posted 15 days ago