GAMP Jobs in Boston, MA

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Reliability Engineer

Cushman & Wakefield

•

Boston, Massachusetts, USA

Full-time

Job Title Reliability Engineer Job Description Summary As a key member of the Reliability Engineering team, the lead Reliability Engineering will provide strategic and hands-on support for GxP Facility Operations and Engineering across Vertex GxP sites. This role will drive the implementation of maintenance and reliability best practices, focusing on maximizing equipment and system performance while ensuring compliance with GxP and Good Engineering Practices (GEP). The ideal candidate will lead
Posted 15 days ago | Updated 12 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 10 days ago | Updated 12 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

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 59 days ago | Updated 12 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 14 days ago | Updated 12 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 28 days ago | Updated 8 hours ago

Computer System Validation Lead

Nityo Infotech Corporation

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Remote

Third Party, Contract

Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, 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 Gu
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Posted 3 days 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 21 days ago | Updated 12 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

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 11 days ago | Updated 12 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

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 12 hours 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 13 days ago | Updated 5 days ago

Donor-Advised Fund Accountant

GSS Infotech

•

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 10 days ago

Financial Analyst II

Noise Consulting Group

•

Waltham, Massachusetts, USA

Contract

Description: Key Accountabilities: Develop a deep understanding of our regulatory allowances and obligations, and accounting policies Maintain financial reporting for Electric Sector Modernization Plan Develop portfolio and project level accounting, tracking, and reporting capabilities Maintain and update project and portfolio forecasts over multiple time horizons Verify project actuals and perform variance analysis to identify deviations from forecast Perform various financial operations includ
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Posted 19 days ago

Raw Materials Technical Specialist

Aditi Consulting

•

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 9 hours ago | Updated 6 hours ago

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

Kellton

•

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 18 days ago | Updated 7 days ago

Insurance Tax Manager - Federal & State

MassMutual

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Boston, Massachusetts, USA

Full-time

Insurance Tax Manager - Federal & State Corporate Tax Full-Time Boston, MA or Springfield, MA The Opportunity As a member of the Domestic Tax Unit, you'll have an opportunity to join an engaged team of professionals who work to reduce the Company's exposure to tax risks, support M&A transactions, provide high-quality tax advice, and satisfy tax accounting, reporting, and compliance requirements for the Company's domestic life insurance companies and its non-insurance subsidiaries. This is a
Posted 1 day ago | Updated 15 hours ago

AXIS Modeling Actuary

MassMutual

•

Boston, Massachusetts, USA

Full-time

Actuary Life Valuation Modeling Team, Corporate Actuarial Full-Time Boston, MA or Springfield, MA or NY,NY The Opportunity At MassMutual, we're dedicated to helping people secure their future and protect the ones they love. The Corporate Actuarial organization supports this mission with actuarial and business analytics, while providing our employees with meaningful career experience. To support the expanding role and influence of our valuation models, we are hiring an Actuary for the Life Val
Posted 7 days ago | Updated 15 hours ago

Engineer II, Process Development

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 Objective / Purpose: The individual will be a member within a group responsible for performing upstream and downstream related proces
Posted 4 days ago | Updated 12 hours ago

Head of Annuity Valuation Reporting

MassMutual

•

Boston, Massachusetts, USA

Full-time

The Opportunity The Head of Annuity Valuation will lead the team responsible for the valuation of MassMutual's Retail and Institutional Annuity business, reporting to the Head of Valuation. This leadership role within the Valuation department will drive the delivery of accurate and timely financial reporting information and analysis that is actionable and forward-thinking. This leader will be a trusted partner to various internal and external stakeholders and manage a team of actuarial professio
Posted 7 days ago | Updated 15 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Norwood, Massachusetts, USA

Full-time

Job Description: The purpose of the Validation Engineer (contract position) is to complete assignments in support of Quality and Engineering for equipment qualification, new product development, process validation and test method validation. The successful candidate will assume responsibility for drafting qualification protocols, qualification reports and engineering study reports, along with data analysis and an intermediate level of experience in the use of statistics. This position will also
Posted 8 days ago | Updated 12 hours ago

Change Management Analyst

HS Solutions

•

Boston, Massachusetts, USA

Contract

Must have Skills: Accounting, Billing, Business Analysis, Change Management, GAAP, Grant Management, OCM (Organizational Change Management), Procurement. Required Education: Bachelor s degree in related field Required Skills: 3 - 5 years experience with change management coordination in a large organization Experience with transformational change initiatives and how to prepare people for technology change Capable of building trusted relationships with front-line leaders and employees at all le
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Posted 20 days ago