gams Jobs in boston, ma

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Software Engineer with Syncade @ Boston, MA

Hermitage Info Tech, LLC.

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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 1 day 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 17 days ago | Updated 6 hours 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 6 hours ago

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

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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 13 days ago | Updated 6 hours ago

Senior Validation Engineer

Takeda pharmaceutical

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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 17 days ago | Updated 6 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 2 days ago | Updated 2 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 31 days ago | Updated 2 hours ago

Senior Automation Engineer

Takeda pharmaceutical

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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 24 days ago | Updated 6 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 16 days ago | Updated 8 days 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 21 days ago | Updated 6 hours ago

DeltaV Automation Engineer

Fynbosys Inc

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Remote or Muskegon, Michigan, USA

Contract

Title : Sr/Lead DeltaV Automation Engineer Location - Muskegon, MI (Onsite) Cognizant JD : This is a remote position open to any qualified applicant in the United States.We are open to considering remote candidates who are willing to travel frequently to client sites at Muskegon MI. Travel Requirement : The travel requirements include an initial three weeks to overlap with another senior engineer. Subsequently, the schedule is anticipated to be two weeks of travel to Muskegon MI followed by thr
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Posted 11 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 11 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