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Software Engineer with Syncade @ Boston, MA

Boston, Massachusetts

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2d ago

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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Contract

$40 - $50

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

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

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

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

QA Lead Technical Operations

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

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

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. 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

Full-time

compliance lead

Remote

•

Yesterday

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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Contract

Depends on Experience

DeltaV Automation Engineer

Remote or Hybrid in Muskegon, Michigan

•

Yesterday

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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Contract

Depends on Experience

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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8d 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

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Contract

Depends on Experience

Donor-Advised Fund Accountant

Hybrid in Boston, Massachusetts

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14d 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

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Full-time

$60,000 - $80,000

Raw Materials Technical Specialist

Remote or Hybrid in Cambridge, Massachusetts

•

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

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Contract

$38 - $40 hr

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

Hybrid in Boston, Massachusetts

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11d 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

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Contract, Third Party

Depends on Experience

Change Management Analyst

Boston, Massachusetts

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24d 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

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Contract

$40 - $45

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

SR. Business Analyst (Independent Contractors Only)

Boston, Massachusetts

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2d ago

Job Title: SR. Business AnalystLocation: Boston, MA (Hybrid)Job Type: Contract (Independent Contractors Only)Local Candidates Preferred Certifications Required:Certified Business Analysis Professional (CBAP) Chartered Financial Analyst (CFA) Job Summary:We are seeking a highly skilled Senior Business Analyst (SCD Analyst) with expertise in Investment Accounting, Capital Markets, Transaction Management, CR Interfaces, Security Master, and Finance. The ideal candidate will have deep knowledge of A

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Third Party, Contract

Depends on Experience

Validation Engineer

Norwood, Massachusetts

•

Today

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

Full-time

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