fda Jobs in new jersey

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Automation Control Engineer

Katalyst Healthcares and Lifesciences

•

South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa
Posted 60+ days ago | Updated 9 hours ago

Mechanical & Biomedical Engineer

Katalyst Healthcares and Lifesciences

•

Belleville, New Jersey, USA

Full-time

Responsibilities: Lead/contribute to device development, design controls and risk management strategy for the assigned projects. Lead the implementation and/or ensure effective execution of the device development strategy, design controls and risk management activities for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers. Proactively resolve project
Posted 60+ days ago | Updated 9 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
Posted 60+ days ago | Updated 9 hours ago

PMO Project Manager with a background in regulated environments

Combined Computer Resources

•

Ewing Township, New Jersey, USA

Contract

Role Summary The Project Manager is the single point of accountability for the delivery of one or more medium to large, complex business information technology projects involving multiple functions, delivering substantive value to business areas. This includes the structuring and detailed planning of the project work, management of the day-to-day work activities of the project, ensuring compliance to all applicable client processes, managing project scope, issues, risk, resources (internal and e
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Posted 14 hours ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 10 days ago | Updated 9 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Raritan, New Jersey, USA

Full-time

Role & Responsibilities: 3-7 years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area. Has working experience in any one or two of the following domains Tool validation like ServiceNow, Automation tools, JIRA . Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. pplication of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 2
Posted 60+ days ago | Updated 9 hours ago

Manufacturing Technical Writer--EAM

Eliassen Group

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Anywhere, US

Contract

Description: **Hybrid onsite | 3x a week | Mesa, AZ** Our client has an exciting opportunity for a Manufacturing Technical Writer--EAM. Due to client requirement, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $25 - $35 / hr. w2 Responsibilities: Rewrite Process Instructions for new Asset Management system, working w
Posted 2 days ago | Updated 9 hours ago

IT Enterprise Architect with Life Science Experience

K Source Inc

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Remote

Contract, Third Party

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: IT Enterprise Architect with Life Science Experience Location: Boston, MA (Remote) Duration: 12+ months Job Description: The IT Enterprise Architect is a key role within Gates MRI IT, combing a blend of deep technical and architectural expertise with industry foresight, and strategic thinking. This position is essential for crafting a cohesive IT architecture that sup
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Posted 5 days ago

Vendor Management Analyst

Beacon Systems, Inc

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Remote

Contract, Third Party

About Radiant Digital, IncRadiant Digital, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Services. We have a vast portfolio of clients across the country. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide.Position: Program Vendor Management -Bus
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Posted 2 days ago | Updated 14 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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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 29 days ago | Updated 9 hours ago

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 30 days ago | Updated 9 hours ago

Senior Appian Developer - REMOTE

General Dynamics

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Remote

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: Appian Level 1 Credential Certification - Appian Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fi
Posted 51 days ago | Updated 9 hours ago

GongRevenue Intelligence Admin

Beacon Systems, Inc

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Remote

Contract, Third Party

About Radiant Digital, IncRadiant Digital, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Services. We have a vast portfolio of clients across the country. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Gong Revenue Intelligence A
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Posted 14 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Summit, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems. Develops
Posted 19 days ago | Updated 9 hours ago

Senior Engineer, Product Development - R&D

Stryker

•

Mahwah, New Jersey, USA

Full-time

Work Flexibility: Hybrid or Onsite Stryker Joint Replacement Division, based in Mahwah, NJ, Hip Business Unit is currently seeking a Senior Engineer, Product Development (PD) to support the Hip Business Unit. Know more about the Joint Replacement Hip Unit: Hip Business Unit What You Will Do: Device Design & Problem Solving: Research, design, develop, modify, and verify mechanical components for medical devices; translate design inputs into engineering specifications; and apply , both fundamen
Posted 9 days ago | Updated 9 hours ago

USA-Process Engineer III (Engineering)

Katalyst Healthcares and Lifesciences

•

Morristown, New Jersey, USA

Full-time

Responsibilities: Support activities within MSAT-US regarding technical documentation, SOP's, and internal systems. Development of technical positions regarding packaging and Pharma process, equipment, material and component performance and Regulatory compliance for Client packaging process practices. This includes investigating and recommending new packaging and Pharma processes, technologies, systems, and materials, for potential integration into Client packaging and Pharma manufacturing sys
Posted 60+ days ago | Updated 9 hours ago

Sr. Mechanical Engineer

Katalyst Healthcares and Lifesciences

•

Rahway, New Jersey, USA

Full-time

Responsibilities: Apply subject matter expertise in mechanical design, analysis, and system development. Conceive and develop solutions to complex analytical, pneumatic, mechanical, and electrical design challenges. Establish design objectives and contribute to writing specifications and comprehensive engineering reports. Participate in the review and development of detailed product specifications. Conduct conceptual and detailed design studies using MCAD, Solidworks, and other tools. Coll
Posted 57 days ago | Updated 9 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 18 days ago | Updated 9 hours ago

Senior Clinical Outcomes Assessment (COA) Lead

Sanofi

•

Morristown, New Jersey, USA

Full-time

Job Title: Senior Clinical Outcomes Assessment (COA) Lead Location: Cambridge, MA, Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to incorporate the patients' perspective (and other subjective perspectives) into clinica
Posted moments ago

GRA CMC Project Lead

Sanofi

•

Morristown, New Jersey, USA

Full-time

Job Title: GRA CMC Project Lead Location: Morristown, NJ Framingham, MA About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Chemistry, Manufacturing and Controls (CMC) regulatory team is accountable for the global regulatory strategy for development and marketed products within GRA. The team responsibil
Posted moments ago