GAMP Jobs in Massachusetts

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Software Engineer with Syncade @ Boston, MA

Hermitage Info Tech, LLC.

•

Boston, Massachusetts, USA

Contract

Day 1 onsite Role: Software Engineer with Syncade Boston, MA Qualifications Thorough understanding of ISA S88 and S95 models Knowledge of CSV, GAMP and 21 CFR Part 11 regulations Bachelor's degree in Chemical/Electrical/Computer Engineering, or equivalent combination of education and technical experience Minimum four (4) years of design/development/deployment experience in Emerson Syncade MES DeltaV Batch programming or Syncade Recipe development experience Work experience in a Pharmaceutical/
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Posted 2 hours ago

QA Lead Technical Operations

LOGIXtech Solutions

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Harvard, Massachusetts, USA

Contract

Our client, a leading pharmaceutical company, is hiring a QA Lead - Technical Operations, on a contract basis. Job ID: 82974 Work Location: Devens, MA - on site Education/Experience: Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering biochemistry, or related discipline, or its equivalent is preferred. Advanced Level of relevant experience in a GMP, Google Cloud Platform, or GXP with at least 8 years focused on product quality. Preferred
Posted 20 hours ago | Updated 8 hours ago

QA Lead Technical Operations

System One

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Ayer, Massachusetts, USA

Contract

Job Title: QA Lead Technical Operations Location: Devens, MA Compensation: $60 - $65 hourly Schedule: M - F 1 st Shift Type: Contract, Potential for extension or conversion to permanent Responsibilities Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations Reviews and approves Quality, Qual
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Posted 21 hours ago | Updated 9 hours ago

QA Lead Technical Operations

TSR Consulting Services, Inc.

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Harvard, Massachusetts, USA

Contract

Our client, a leading pharmaceutical company, is hiring a QA Lead - Technical Operations, on a contract basis. Job ID: 82974 Work Location: Devens, MA - on site Education/Experience: Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering biochemistry, or related discipline, or its equivalent is preferred. Advanced Level of relevant experience in a GMP, Google Cloud Platform, or GXP with at least 8 years focused on product quality. Preferred
Posted 20 hours ago | Updated 8 hours ago

SAP Integration Lead

Judge Group, Inc.

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Boston, Massachusetts, USA

Contract

Location: Boston, MA Salary: $75.00 USD Hourly - $80.00 USD Hourly Description: Job Title: SAP Integration Lead Location: Boston, MA (Hybrid) Duration: 6+ months Contract Need Locals Only Required Qualifications: Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field8+ years of SAP integration experience, with 3+ years in a regulated pharmaceutical environmentExpertise in SAP CPI, PI/PO, IDoc/ALE, RFC, BAPI, and API-based integrationStrong understanding of SAP
Posted 29 days ago | Updated 8 hours ago

Senior Validation Engineer

Takeda pharmaceutical

•

Lexington, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by
Posted 16 days ago | Updated moments 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. uthor 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 degree
Posted 13 days ago | Updated moments ago

Reliability Engineer

Cushman & Wakefield

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Boston, Massachusetts, USA

Full-time

Job Title Reliability Engineer Job Description Summary This individual will provide support for GxP Facility Operations/Engineering department at Vertex GxP sites as part of the Reliability Engineering team. The ideal candidate will be responsible for ensuring the reliability and performance of our equipment/systems through Reliability best practices and continuous improvement initiatives. This role will also execute documentation/forms/spreadsheets to roll out Maintenance and Reliability Best
Posted 16 days ago | Updated 11 hours ago

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

•

Lexington, Massachusetts, USA

Full-time

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment. Execute approved protocols per company Good Documentation Practices (cG
Posted 12 days ago | Updated moments ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 60+ days ago | Updated moments 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 moments ago

Senior Automation Engineer

Takeda pharmaceutical

•

Lexington, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role: As a Senior Automation Engineer, you will work in a hybrid position and be part of the Automation engineering group
Posted 23 days ago | Updated moments ago

SAP Finance FICO Consultant

URSI Technologies Inc.

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Remote

Contract

SAP Finance FICO Consultant San Francisco, CA Remote Remote Qualifications The ideal candidate will have hands-on experience in SAP S4HANA and ECC, a strong understanding of GAMP 5, cGMP, and SOX compliance requirements, and proven application support skillsKey Responsibilities: Provide application support for SAP FICO modules within a regulated IT environmentTranslate business requirements into SAP solutions using SAP Best Practices, FIORI apps, and embedded analyticsJob description : 9+ to 15
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Posted 14 days ago | Updated 6 days ago

Need Senior Manufacturing Quality Engineer

Montek System

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Ayer, Massachusetts, USA

Contract, Third Party

Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM) Top Skills/Must Haves: Quality Control Equipment experience preferredTechnical WriterInvestigations/Deviation experience preferred Job Description/ Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review andapproval of Investigations and Corrective Actions. Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectati
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Posted 6 hours ago

Donor-Advised Fund Accountant

GSS Infotech

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Boston, Massachusetts, USA

Full-time

Donor-Advised Fund Accountant Boston, MA Core Responsibilities Accounting Prepare and analyze monthly, quarterly, and annual financial statements.Ensure the accuracy and completeness of general ledger activity, including journal entries, reconciliations, and adjustments for multiple entities.Assist with the preparation of audited financial statements and related Form 990s and coordinate with external auditors and accountants.Maintain and update accounting policies and procedures specific to dono
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Posted 11 days ago

Full Stack Lead Engineer

Akshaya Inc

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Remote

Contract

Job Description: Tech Stack: LAMP stack migration Node.js, Vue.js, CloudSQL, Google Cloud Platform Key ResponsibilitiesLead migration of legacy LAMP stack applications to modern Google Cloud Platform-based architectureBuild high-traffic, consumer-facing products from the ground upCollaborate with Product, QA, and Ops teams to align engineering effortsDesign and develop new products including prototyping and testingManage full product development life cycleIdentify and resolve technical issues to
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Posted 2 hours ago

Full stack Developer-LAMP

Akshaya Inc

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Remote

Third Party, Contract

Job Title :LAMP Full stack Developer Location: Remote Experience: 15+Years Required Description: Lead efforts to build and migrate features from the current LAMP stack application to Google Cloud using state of the art techstack using NodeJs, VueJS, CloudSQL and Google Cloud technologies. Deep knowledge building full stack apps using VueJS, NodeJS, HTML5, CSS3, JavaScript and microservices. Working knowledge of PHP applications and ideally have experience migrating them.
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Posted 2 hours ago

Raw Materials Technical Specialist

Aditi Consulting

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Remote or Cambridge, Massachusetts, USA

Contract

Payrate: $38.00 - $40.00/hr. Summary: The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing t
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Posted 1 day ago | Updated moments ago

*Organizational Change Management Analyst/Readiness Liaison* (Remote with travel)

Kellton

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Boston, Massachusetts, USA

Contract, Third Party

Kellton Tech is a full-service software development company, offering end-to-end IT solutions, strategic technology consulting and product development services in Web, SMAC (Social, Mobile, Analytics, Cloud), ERP-BPM, and IoT space Our methodology of inventing infinite possibilities with technology helps us develop best in-class and cost effective solutions for our clients. Currently Kellton Tech is looking for talented resources for one of our listed client. Below are the position details: Posi
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Posted 20 days ago | Updated 9 days ago

Tagetik Technical Support

OnwardPath Technology Solutions LLC

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Remote

Contract

Finance/Accounting Degree preferred, and/or at least 10 years in accounting (focus in Financial Closing and Consolidation required; exposure to Foreign Currency is preferred)Deep understanding of the Tagetik architecture and modules (Financial Close, Budgeting & Planning, IFRS/GAAP Consolidation, Financial Reporting).Experience in configuring and customizing Tagetik solutionsExperience with SDLC (System Design Life Cycle) and deployment in Tagetik projects
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Posted 22 days ago | Updated 5 hours ago