FDA Jobs in Michigan

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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

Business Analyst

NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE) Job Description: Experience Level: 7 9 years of relevant experience Role Overview: The Business Analyst (BA) w
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Posted 20 days ago | Updated moments ago

PTC Arena Consultant

Teknikoz

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Remote

Contract, Third Party

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 27 days ago | Updated 27 days ago

Program Manager Governance with GenAI

Kodeva LLC

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Remote

Contract, Third Party

Role: Program Manager, Governance with GenAI Duration: 12 months Location: Remote Role Summary: Define, enforce, and scale governance practices for data, models, and GenAI tools. Responsibilities: Establish model validation, audit, and documentation standards across the ML lifecycle Develop policies for GenAI prompt controls, review workflows, and user accountability Manage intake and approval process for model deployment and usage rights Lead internal audit efforts and regulatory documentation
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Posted 7 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract, remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Active
Posted 18 days ago | Updated 15 days ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract , remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Acti
Posted 18 days ago | Updated 15 days ago

Drug Safety Scientist

Sunrise Systems, Inc.

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Remote

Contract

Job Title Drug Safety Scientist Job ID: 25-08470 Location: 100% Remote (Candidates should be in EST only) Duration: 12 months on W2 Contract Summary: Seeking an experienced Drug Safety Scientist with 5+ years in pharmacovigilance to support regulatory safety reporting and risk management. Must hold a Bachelor's/Master s in Pharmacy, Biotechnology, or Chemistry. Key Responsibilities: Author safety reports (DSUR, PBRER, PADER)Support signal detection and safety data evaluationConduct literature
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Posted 30 days ago | Updated moments ago

DeltaV Automation Engineer - Pharmaceuticals

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is hiring a DeltaV Automation Engineer for a growing BioPharma company located in Holly Springs, NC. The DeltaV Automation Engineer will be responsible for designing, developing, and maintaining automation systems for pharmaceutical manufacturing processes. This role requires expertise in Emerson DeltaV DCS (Distributed Control System), with a focus on process optimization, validation, and compliance with industry regulations. The DeltaV Automation Engineer can work remote, but w
Posted 15 days ago | Updated 15 days 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 49 days ago | Updated 1 hour 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 1 day ago | Updated 1 hour ago

Engineer III, Validation

Thermo Fisher Scientific

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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 2 days ago | Updated 1 hour ago

Performance Test Engineer (Broadband)

Beacon Systems, Inc

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Remote

Contract

eacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. 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. We are looking for a Performance Test Engineer - Remote Request you to make sure your updated Resume highlights all the be
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Posted 1 day ago | Updated 6 hours ago

Cloud Engineer

ICF

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New Jersey, USA

Full-time

Please note: This role is contingent upon contract award. While it is not an immediate opening, we are actively conducting interviews and extending offers in anticipation of the award. The Work We are seeking a skilled and security-focused Cloud Engineer to support mission-critical systems for our federal government client. The ideal candidate will have experience architecting, deploying, and managing cloud solutions in compliance with government cybersecurity frameworks such as FedRAMP, NIST,
Posted 4 days ago | Updated 1 hour ago

Manager, Software Development

Fresenius Medical Care

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Remote or Concord, California, USA

Full-time

Manager, Software Development, Fresenius USA, Inc., a Fresenius Medical Care N.A. company, Martinez, California (Hybrid) Responsible for directing software systems development, software application development, and software quality assurance for software enhancements and new products including cloud-based and/or internet-related tools. Will manage a team of software developers to design, code, test, and implement high quality software for dialysis and related products. Will also be responsible
Posted 10 days ago | Updated moments ago

Lead Engineer MES Opcenter

Zettalogix INC

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Remote

Third Party, Contract

Position: Lead Engineer MES Opcenter RemoteDuration: 6 months with opportunity for extension or conversion Job Description: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 responsible for leading resources contracted via a third-party and through other client organizations to develop & deploy MES application software to Medical Device manufacturing s
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Posted 6 days ago | Updated 1 day ago

Senior Appian Developer

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: None Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on
Posted 23 days ago | Updated moments ago

CQV Engineer (Onsite) Location:Kalamazoo, Michigan

Stellent IT LLC

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Kalamazoo, Michigan, USA

Contract, Third Party

CQV Engineer(Onsite) Location:Kalamazoo, Michigan Interview:Phone+Skype Job Description: Overview: The qualified Validation Engineer will support multiple workstreams including prep/form, fill/freeze dry, utilities, etc. While these are the key workstreams, the ability to shift priorities and prove experience across a range of equipment is highly desired. The ideal candidate should hold large scale aseptic Process Equipment C&V experience, needs to be independent with insightful understanding
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Posted 16 days ago | Updated 3 hours ago

JD Edwards EnterpriseOne Technical Consultant / Developer - short-term project starting immediately

ennVee TechnoGroup, Inc

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Remote

Contract

Job Title: JD Edwards EnterpriseOne Technical Consultant Job Summary We are seeking experienced JD Edwards (JDE) EnterpriseOne Technical Consultants to support our client s ongoing application development and integration initiatives. The ideal candidates will have a strong background in JDE technical toolsets, orchestrator development, and third-party system integration (e.g., SOA, OTM, Avalara, Salesforce). Key Responsibilities Design, develop, and maintain custom JDE EnterpriseOne interactive
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Posted 21 days ago | Updated 20 days ago

Remote Senior Appian Developer

Computer Merchant, Ltd., The

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Remote or Rockville, Maryland, USA

Full-time

JOB TITLE: Senior Appian Developer JOB LOCATION: Remote WAGE RANGE*: $75HR TO $80HR JOB NUMBER: 25-02929 REQUIRED EXPERIENCE: MUST OBTAIN A PUBLIC TRUST Skills: Appian BPM, Application Design, Software Development Experience: 10 + years of related experience JOB DESCRIPTION The Food and Drug Administration (FDA) is the federal agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devic
Posted 27 days ago | Updated 9 hours ago

Director, Device Engineering

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 3 days ago | Updated 1 hour ago