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Harvard, Massachusetts

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Today

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

Contract

USD 64.00 - 65.00 per hour

QA Lead Technical Operations

Harvard, Massachusetts

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Today

Contract

USD 64.00 - 65.00 per hour

SAP Integration Lead

Boston, Massachusetts

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Today

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

Contract

USD 75.00 - 80.00 per hour

Senior Validation Engineer

Lexington, Massachusetts

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Today

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

Full-time

USD 132,000.00 - 193,300.00 per year

Reliability Engineer

Boston, Massachusetts

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Today

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

Full-time

Senior Validation Engineer

Lexington, Massachusetts

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Today

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

Full-time

Senior Automation Engineer

Lexington, Massachusetts

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Today

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

Full-time

USD 86,500.00 - 135,960.00 per year

Validation Support Engineer

Boston, Massachusetts

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Today

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

Full-time

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

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

Full-time

Computer System Validation Analyst - R Studio & Clinical Systems

Remote or New Jersey

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Today

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

Full-time

SAP Finance FICO Consultant

Remote

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6d ago

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

Easy Apply

Contract

Depends on Experience

Donor-Advised Fund Accountant

Hybrid in Boston, Massachusetts

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11d ago

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

Easy Apply

Full-time

$60,000 - $80,000

Raw Materials Technical Specialist

Remote or Hybrid in Cambridge, Massachusetts

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Today

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

Easy Apply

Contract

$38 - $40 hr

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

Hybrid in Boston, Massachusetts

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8d ago

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

Easy Apply

Contract, Third Party

Depends on Experience

Change Management Analyst

Boston, Massachusetts

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21d ago

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

Easy Apply

Contract

$40 - $45

Insurance Tax Manager - Federal & State

Boston, Massachusetts

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Today

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

Full-time

AXIS Modeling Actuary

Boston, Massachusetts

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Today

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

Full-time

Head of Annuity Valuation Reporting

Boston, Massachusetts

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Today

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

Full-time

Engineer II, Process Development

Lexington, Massachusetts

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Today

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

Full-time

USD 70,000.00 - 110,000.00 per year

Embedded Software Architect - hybrid in Bedford

Boston, Massachusetts

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Today

Our client is seeking a Software Architect with Medical Device experienceto join their team in Bedford, Ma, on a hybrid schedule. In this role, you will oversee the use of technology, architecture and design practices for a specific product line. They are looking for someone to effectively communicate with business stakeholders, as well as work on legacy products and brand-new products, setting the future of the product line and bridging the gap between future products and technology Responsibi

Easy Apply

Full-time

170k - 190k

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