FDA Jobs in New York, NY

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W2 only Software Quality Assurance Consultant - EST/CST Only - regulatory affairs Medical Devices, software development life cycle risk management and configuration management FDA

APN Software Services, Inc

•

Remote

Contract

Please contact Abdul on "" OR email me at "" Job Responsibilities: Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements. 2. Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test pl
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Posted 6 days ago | Updated 1 day ago

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
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Posted 58 days ago | Updated moments ago

Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)

Amerit Consulting

•

Remote

Contract

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Software Program Manager NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099) Candidate must be authorized to work in USA without requiring sponsorship Position: Medical Devices Software Program Manager(Job Id - # CFNJP00051124) Location: San Diego CA 92130 (Remote) Duration: 6 months + Contract to
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Posted 9 days ago | Updated moments ago

Business Quality Assurance (BQA)

Activesoft, Inc.

•

Remote

Contract

Mandatory Skills & Qualifications: Strong knowledge in GMP, cGMP, and regulatory standards:21 CFR Part 1121 CFR Part 21021 CFR Part 211ICH Q7Experience facing FDA audits at pharmaceutical manufacturing sitesHands-on experience with manufacturing processes, CAPAs, deviations, etc.Lead Auditor or any other compliance certifications (preferred)
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Posted 25 days ago | Updated 3 hours ago

PTC Arena Consultant

Teknikoz

•

Remote

Third Party, Contract

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an
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Posted 23 hours ago | Updated 23 hours ago

CQV Engineer

Katalyst Healthcares and Lifesciences

•

Brooklyn, New York, USA

Full-time

Responsibilities: Develop commissioning and qualification protocols for HVAC, purified water systems, clean utilities, and other critical utilities according to regulatory requirements (GMP, FDA, etc.). Execute commissioning and qualification activities for utilities systems, ensuring adherence to project schedules and quality standards. Conduct risk assessments, impact assessments, and gap analyses related to utilities systems. Coordinate with cross-functional teams including engineering, q
Posted 22 days ago | Updated 7 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 22 days ago | Updated 7 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

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 22 days ago | Updated 7 hours ago

Warehouse Technician

System One

•

Jersey City, New Jersey, USA

Full-time

Job Title: Warehouse Technician Location: Jersey City, New Jersey Type: Direct Hire Schedule: Monday-Friday, 9:00 AM - 5:00 PM Industry: Biotechnology / Medical Device Comments: (near Exchange Place, Convenient to Light Rail) Position Summary: We are seeking a hands-on and detail-oriented Warehouse Technician to join a growing biotechnology device company in Jersey City. In this role, you will manage inventory, shipping, receiving, and order fulfillment using electronic warehouse management
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Posted 18 hours ago | Updated 6 hours ago

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 22 days ago | Updated 7 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Allendale, New Jersey, USA

Full-time

Responsibilities: Work under the direction of the Validation Lead and/or function as the validation lead for a project team. The Validation Engineer will be required to support multiple projects simultaneously. Develop and execute IQ, OQ, and PQ protocols for products, processes, facilities, software, and equipment within the facility. Experience authoring Validation Plan documents, User Requirements, Traceability Matrix, and Validation Summary Reports. Write reports summarizing results and s
Posted 22 days ago | Updated 7 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 2 days ago | Updated 7 hours ago

Validation Lead with SAP

Katalyst Healthcares and Lifesciences

•

South Plainfield, New Jersey, USA

Full-time

Responsibilities: To create| assign and track the project [module] work plans for delivery and provide technical guidance for work completion. Ensure process improvement and compliance in the assigned module| and participate in technical discussions/review. Create work plans| monitor and track the work schedule for on time delivery as per the defined quality standards. Prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations. Develop and guide
Posted 22 days ago | Updated 7 hours ago

Analytical Test Method Validation Engineer

Katalyst Healthcares and Lifesciences

•

South Plainfield, New Jersey, USA

Full-time

Develop, validate, and implement analytical test methods for combination products in compliance with regulatory standards and internal quality requirements. Collaborate cross-functionally with device engineers, laboratory teams, and quality departments to ensure alignment and successful execution of test method validation (TMV) activities. Provide expert guidance on analytical strategies for device-related products, ensuring robust and reproducible methods are established. Evaluate and optimize
Posted 22 days ago | Updated 7 hours ago

Process Engineer

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 Company packaging process practices. Investigating and recommending new packaging and Pharma processes, technologies, systems, and materials, for potential integration into Company packaging and Pharma manufacturing systems. Provi
Posted 22 days ago | Updated 7 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 22 days ago | Updated 7 hours ago

Engineer III, Validation

Thermo Fisher Scientific

•

Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the
Posted 9 days ago | Updated 8 hours ago

Industrial Maintenance Technician

fgf brands

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Brooklyn, New York, USA

Full-time

Job Description: Maintenance Technician "To become the world?s greatest baker, we need the world?s greatest team members! Location: Brownsburg, IN Starting Wage:$34.75 per hour +$1/hour shift differential for night shift2 opportunities for performance raises in your first year20% built-in overtimeSchedules Available: We work a modified 2-2-3 schedule working 12-hour day or night shifts. Nights: 6:00pm-6:00am; +20% built in overtime (48-hour weeks)Days: 6:00am-6:00pm; +20% built in overtime (48
Posted 60+ days ago | Updated 9 hours ago

Salesforce BA with Health Cloud (Life Sciences domain)

Technogen, Inc.

•

Edison, New Jersey, USA

Contract, Third Party

TECHNOGEN, Inc. is a Proven Leader in providing full IT Services, Software Development and Solutions for 15 years. TECHNOGEN is a Small & Woman Owned Minority Business with GSA Advantage Certification. We have offices in VA; MD & Offshore development centers in India. We have successfully executed 100+ projects for clients ranging from small business and non-profits to Fortune 50 companies and federal, state and local agencies. Salesforce BA with Health Cloud (Life Sciences domain) Location: Ed
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Posted 1 hour ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks, functions, and uses basi
Posted 22 days ago | Updated 7 hours ago