21 - 40 of 144 Jobs

Test Lead

radient.ai

King of Prussia, Pennsylvania, USA

Contract

Job Title/Role Test Lead Project Start date Asap Project Duration 6+ Months Client Interview Needed for Selection (Yes / No) Yes Job Location/Client Location (with City & State) King of Prussia, PA Remote ok (Yes / No) No Mode (TP/FTE) TP Exclusive to HCLTech (Y/N) Y No of openings/positions 1 Mandatory Skills P : AWS Cloud Migration, Database Migration S: GXP, Agile, Hand on in ALM/Codebeamer, Life Science Domain. JD - Hands on experience with AWS Cloud migration testing. - Hands on experie

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

Remote

Contract, Third Party

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce

Argus SME

Intone Networks Inc.

Raleigh, North Carolina, USA

Third Party, Contract

Job Title - Argus SME Location - Raleigh, NC Hire Type -Contract Job description: 10 12+ years of IT experience in the Life Science Area Good domain knowledge in PV Argus Configuration/customization Argus Support as per ITIL process Hands-on experience in GxP Application support and Enhancement Must-Have: Knowledge of CSV process for Pharma Years of Experience: 12.00 Years of Experience

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

Sr. IT Project Lead

Horizontal Talent

US

Contract

We are seeking a talented and motivated Sr. IT Project Lead to join our dynamic team. This role offers the opportunity to lead the implementation of innovative laboratory systems in a remote work environment. Responsibilities Lead the implementation of a new Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) across the organization. Collaborate with cross-functional teams to gather requirements and ensure alignment with lab workflows. Conduct gap analysis and impac

LIMS and QC Applications Consultant

Expedite Technology Solutions

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

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

Senior Laboratory Application Engineer, Application Development and Maintenance

Cardinal Health

No location provided

Full-time

What Application Development & Maintenance contributes to Cardinal Health Information Technology oversees the effective development, delivery, and operation of computing and information services. This function anticipates, plans, and delivers Information Technology solutions and strategies that enable operations and drive business value. Application Development & Maintenance performs configuration or coding to develop, enhance and sustain the organization's software systems in a cross-function

Global IT Compliance Sr Specialist

Thermo Fisher Scientific

Pennsylvania, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so

CSV Engineer Role

Katalyst Healthcares and Lifesciences

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

System Validation Engineer

Katalyst Healthcares and Lifesciences

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi

Medical Device Engineer

Katalyst Healthcares and Lifesciences

North Chicago, Illinois, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi

Validation Lead

TechDigital Corporation

King of Prussia, Pennsylvania, USA

Third Party, Contract

Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterf

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

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil

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. 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

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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

Cloud Data Engineer

CyberOne LLC

Chicago, Illinois, USA

Full-time, Third Party

We are seeking an experienced Cloud Data Engineer with a strong background in cloud platforms (AWS, Snowflake, Azure DevOps) and proficiency in Python and Spark. The ideal candidate will have 8 10 years of industry experience, preferably in the Life Sciences or Pharmaceutical domain, with hands-on expertise in cloud data integration and data migration projects. Knowledge of data warehousing concepts and best practices is highly desirable. Key Responsibilities:Design, develop, and maintain scalab

Labware LIMS Specialist

Quantum World Technologies Inc.

Kent, Connecticut, USA

Full-time, Contract, Third Party

Be Labware certified Strong Concepts of LIMS LabWare V6 V7V8 Detailed knowledge on Labware LIMS Architecture Labware Database Structures SAP Crystal Reports Oracle PLSQL Experience on implementing top tier LabWare LIMS implementation Hands on Experience in LIMS application development LIMS basic Language Subroutines Interfacing Upgrade and validation Experience in Labware Modules like LIMS Stability EM Inventory Storage Location Management Instrument Interfaces Lot Sample Management for Cli

Application Architect

TEKsystems c/o Allegis Group

North Chicago, Illinois, USA

Full-time

MUST HAVE PROVEN ARCHITECT EXPERIENCE & EXPERIENCE WORKING WITHIN MEDICAL DEVICE/PHARMA/HEALTHCARE OR SIMILAR INDUSTRY Description We are seeking a highly skilled 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