GxP Jobs

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Engineer III, Validation

Thermo Fisher Scientific

•

Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 1 day ago | Updated 5 hours ago

Facilities Technician

Zachary Piper Solutions, LLC

•

Manchester, New Hampshire, USA

Full-time

Piper Health & Sciences is seeking a motivated Facilities Maintenance Technician to join a professional biotechnology organization in the Manchester, NH area. Responsibilities for the Facilities Maintenance Technician: Perform general maintenance of the facilities, including GxP laboratory spaces, manufacturing suites, heating, electrical, and/or plumbing. Complete open maintenance tasks such as painting, patching, hanging shelves, connecting gas lines, handling plumbing issues, etc. Safely oper
Posted 14 days ago | Updated 14 days ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Raritan, New Jersey, USA

Full-time

Responsibilities: This resource will support the following related to our Service Industrialization (SI) project Review the Services SI excel spreadsheets for tools, applications and other technologies required to provide the service. There are about 21 spreadsheets Design and set up Mapping Structure for TS Services in SharePoint List Record the technologies from the excel spreadsheets in the Mapping Structure for each Service. Collect the CMDB information for each technology pulled from the sp
Posted 42 days ago | Updated 5 hours ago

Finance Manager

Aditi Consulting

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West Greenwich, Rhode Island, USA

Contract

Payrate: $50.00 - $53.00/hr. Responsibilities: Financial reporting for Gross expenses and headcount for multiple functional areas, capital projects, depreciation, utilities. Month end close activities including reporting packages and accruals. Forecast and Budget for both Functional areas and Capital. Provide financial planning and analysis services to area(s) assigned. Provide analytical support to senior management in preparing long-range plans, annual budgets, rolling forecasts, and review
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Posted 22 hours ago | Updated moments ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated moments ago

CSV Engineer Role

Katalyst Healthcares and Lifesciences

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Massachusetts, USA

Full-time

Job Description: The CSV Engineer will be responsible for validating and verifying computerized systems that control or interface with laboratory equipment, ensuring data integrity and compliance. This includes writing, reviewing, and executing validation documents in alignment with regulatory expectations. Responsibilities: Validate GxP computerized systems/analytical instruments such as liquid handlers, Cellaca MX, and robotic arms. Lead development and execution of Data Integrity documentat
Posted 31 days ago | Updated 5 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 31 days ago | Updated 5 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 47 days ago | Updated 5 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Jersey City, New Jersey, USA

Full-time

Responsibilities: Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix. Possesses strong communication skills to interact with business stakeholders (Technology Leader, Project Manager, Business Owner). Ability to work with project team to facilitate intera
Posted 47 days ago | Updated 5 hours ago

Lead Engineer MES OpCenter

New York Technology Partners

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Remote

Contract

Job Title: Lead Engineer MES OpCenter Location: 100% Remote Experience: 12+ Years JD: Lead Engineer MES OpCenter The Lead Engineer will lead a team of technical resources to design, develop, configure and test MES (Manufacturing Execution Systems) solutions. They will be directly responsibility for leading resources contracted via a third-party and through other J&J organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. The Lead Engineer will b
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Posted 19 days ago

Machine Learning Engineer - Biologics R&D

Judge Group, Inc.

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Worcester, Massachusetts, USA

Full-time

Location: Worcester, MA Salary: $75.00 USD Hourly - $85.00 USD Hourly Description: One of our clients is seeking a Machine Learning Engineer to design and implement advanced ML/AI pipelines supporting biologics and genetic medicine R&D. 6-12 month contract, strong potential for extensions Hybrid in Worcester, MA (3 days/week onsite required) Key Responsibilities Design and implement ML pipelines to assess biologics developability, immunogenicity, and manufacturability.Build, tune, and dep
Posted 10 days ago | Updated 2 hours ago

Support Engineer

Veeva Systems

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Columbus, Ohio, USA

Full-time

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation
Posted 18 days ago | Updated 5 hours ago

LIMS Admin Developer

HAN IT Staffing Inc.

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Gaithersburg, Maryland, USA

Contract, Third Party

Role Biocentre Lead / Architect with LIMS & Inventor Management Experience Location Gaithersburg MD On-Site role Type of Hire - Contract/ C2H Contractor Job Description Responsibilities The Biocentre Tech Lead will manage the technology delivery of integration and lab orchestration capabilities, optimizing laboratory hardware and instruments to support HBS Biobanking operations in the new Biocentre facility. High level responsibilities of this role are to: Support the Biocentre IT Team by making
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Posted 19 days ago | Updated 4 days ago

Associate Director IT Compliance & Governance

Zachary Piper Solutions, LLC

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Conshohocken, Pennsylvania, USA

Full-time

Piper Companies is currently looking for an experienced Associate Director of IT Compliance & Governance in Conshohocken, Pennsylvania (PA) to work for an innovative and growing pharmaceutical manufacturer. Responsibilities for the Associate Director of IT Compliance & Governance include: Maintain the Technology Compliance Framework aligned with global regulations, organizational risks, and evolving guidance and industry standards. Lead implementation and maintenance of IT Policy & SOPs in suppo
Posted 26 days ago | Updated 14 days ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

San Juan, San Juan, Puerto Rico

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments. Test planning and strategy. creation and execution of test protocols, scripts and reports.
Posted 47 days ago | Updated 5 hours ago

Salesforce Application Architect + TrackWise Digital

TEKsystems c/o Allegis Group

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North Chicago, Illinois, USA

Full-time

Description We are seeking a highly skilled Salesforce Application Architect to lead the technical design and architecture of a validated Complaints Management System upgrade for a Fortune 100 medical device company. This role is critical in ensuring the system meets enterprise standards, regulatory compliance, and business needs. The ideal candidate will bring deep expertise in enterprise architecture, validated systems, and hands-on experience with Salesforce Service Cloud and TrackWise Digita
Posted 3 days ago | Updated 2 hours ago

SAP CPI Integration Consultant

McKinsol Consulting Inc

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Waltham, Massachusetts, USA

Contract, Third Party

POSITION OVERVIEW : SAP Integration Lead POSITION OVERVIEW : SAP Integration Lead POSITION GENERAL DUTIES AND TASKS : SAP Integration Lead Position Summary: Experienced SAP Integration Lead with deep expertise in designing and delivering robust, scalable, and compliant integration solutions within a pharmaceutical manufacturing environment. Strong technical leadership in SAP integration technologies (CPI, PI/PO, IDoc, APIs), coupled with a solid understanding of GxP, CFR 21 Part 11, and other re
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Posted 20 hours ago | Updated moments ago

Trackwise Digital Architect

VeridianTech

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Texas, USA

Full-time

Trackwise Digital Architect Remote Requirement Experience with designing and implementing IT systems. Experience with understanding specifications, evaluate current application, gather requirements, and work closely with stakeholders to deliver the right solution Experience working and implementing systems using TrackWise Digital platform. Hands on experience in TrackWise Digital Application setup: Permission Sets, Configuring Platform Custom Settings, Configuring Remote Site Settings, E-s
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Posted 60+ days ago | Updated 17 hours ago

MES Support Lead

Cognizant

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Chicago, Illinois, USA

Full-time

Job Summary Application skill Business Analysis / Requirements gathering for MES Electronic Batch record implementation for a pharma client. Experience on Werum PAS-X System Administration, GMBRs, PVL, PMBR?s, Equipment Management, Material Flow, Weigh & Dispense, EBR, MBR & Master Data Designing and developing State Diagrams in MES Determining updates for Master Data, State Diagrams, Experience on SAP-MES interface, L2 integrations, report development Hands on Experience in Werum PAS-X Specif
Posted 21 days ago | Updated moments ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

•

Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 5 hours ago