fda Jobs in philadephia, pa

21 - 40 of 70 Jobs

Computer System Validation (CSV) EngineerJob Title - Computer System Validation (CSV) Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Sr. Toxicology Associate RemoteJob Title - Sr. Toxicology Associate Remote

Generis TEK Inc.Company Name - Generis TEK Inc.

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Remote or Racine, Wisconsin, USA

Contract

We have Contract role Sr. Toxicology Associate-Remote for our client at Racine WI. Please let me know if you or any of your friends would be interested in this position. Position Details: Sr. Toxicology Associate-Remote-Racine WI Location : Racine, WI 53403 (Remote) Project Duration : 10+ Months Contract REQUIRED EDUCATION: PhD or Master s degree in toxicology or a related field TOP 5 REQUIRED SKILLS: 1. 4+ years of human health risk assessment experience 2. Proficiency in toxicity study proto

Site Automation Project EngineerJob Title - Site Automation Project Engineer

Apex SystemsCompany Name - Apex Systems

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Philadelphia, Pennsylvania, USA

Full-time

Job#: 2074785 Job Description: Position Title: Site Engineering Automation Project Engineer Department: Site Engineering Job Location: Philadelphia, PA Contract & Onsite role Position Summary: The Site Engineering Automation Project Engineer will provide automation engineering design and project management support for a facility project located in Philadelphia, PA. This role will primarily be responsible for the Building Automation System (BAS), Environmental Monitoring System (EMS), and as

SAP ECC Transformation SpecialistJob Title - SAP ECC Transformation Specialist

SpiceorbCompany Name - Spiceorb

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Remote

Contract, Third Party

Hello, SpiceOrb is looking for SAP ECC Transformation Specialist Role: SAP ECC Transformation Specialist Location: Remote Duration: 12+ Months Contract Job Description: SAP full transformation is required of SAP ECC -SAP ECC was implemented in 2014; transferred from old ERP instead of utilizing best practices -5 years ago moved to SAP 4/HANA-it was lift and shift -End of life for SAP 4HANA is end of 2025 with end of 2026 extension Management is looking for transition from on prem to cloud: Full

CQV EngineerJob Title - CQV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical

Remote QA Manager with Healthcare Payer and Claims expJob Title - Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)Company Name - Infinite Computer Solutions (ICS)

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Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Summary: We are looking for an experienced QA Healthcare Manager to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: we need someone who understand healthacre paye

Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -ContractJob Title - Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

BiogensysCompany Name - Biogensys

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Remote

Contract

Biogensys is currently hiring a Senior SAS programmer with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Statistical Programmer II: Pharma experience/Remote At least 7-8 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in

Sr. Principal StatisticsJob Title - Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLCCompany Name - PARAKEET WORLD SOLUTIONS LLC

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Remote

Contract

Job Title: Sr. Principal StatisticsLocation: Remote Duration: 6 MonthsEmployment Type: W2 ContractExperience Level: Mid-SeniorEducation Required: Ph.D. or MS in Statistics or BiostatisticsIndustry: Pharmaceuticals Job Summary:The Sr. Principal Statistician will lead statistical activities in clinical trials, from protocol development to final study reporting. The role will also contribute to regulatory filings, in-licensing evaluations, and marketing support. Key Responsibilities:Review protocol

Statistical Programmer needed for Remote Job only EST candidates needed!!!Job Title - Statistical Programmer needed for Remote Job only EST candidates needed!!!

Nam Info IncCompany Name - Nam Info Inc

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Remote or US

Full-time, Third Party, Contract

Dear, Hope you are doing well. Send resumes along with expected bill rates on W2( NO Benefits) or Independent contractors only apply and share to Note : NO 3rd party candidates, or H1's/EAD's/OPT's please. Role :Statistical Programmer II Location :Remote Duration : 6+ months contract EST ZONE CANDIDATES ONLY Statistical Programming II: Key responsibilities At least 5 years of experience in ADaM/TLF. Create, validate, and maintain SAS programs for data analysis, reporting, and submission de

Clinical Data managerJob Title - Clinical Data manager

Intone Networks Inc.Company Name - Intone Networks Inc.

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Remote

Contract, Third Party

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T

Business developer ManagerJob Title - Business developer Manager

Showman StaffingCompany Name - Showman Staffing

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Remote

Full-time

Job Title: Sr.Business Developer Manager Experience: 6+yrs Location: Remote-Travel required-100% client location-Candidates should be in USA Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to bring c

Senior Business Developer ManagerJob Title - Senior Business Developer Manager

Showman StaffingCompany Name - Showman Staffing

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Remote

Full-time

Senior Business Development ManagerJob Title - Senior Business Development Manager

Showman StaffingCompany Name - Showman Staffing

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Remote

Full-time

Job Title: Sr. Business Development Manager Experience: 6+yrs Location: Remote-Travel required-100% client location-Candidates should be in USA Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to brin

compliance leadJob Title - compliance lead

Adva IT Services, Inc..Company Name - Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc

Clinical Communications Analyst - IDAR Experienced EngineerJob Title - Clinical Communications Analyst - IDAR Experienced Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Pennsylvania, 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

Computer System Validation Analyst - R Studio & Clinical SystemsJob Title - Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and LifesciencesCompany Name - 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

Java DevelopersJob Title - Java Developers

Catapult Solutions GroupCompany Name - Catapult Solutions Group

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Remote

Full-time

Senior Full Stack Engineer (Java + Angular) Direct Hire Remote (with travel as needed for company meetings) About Company Join a forward-thinking organization delivering regulated SaaS solutions that improve the lives of end-users and meet high standards in quality, scalability, and compliance. Our collaborative environment values innovation, mentorship, and excellence in engineering practices. Job Description We are seeking a Senior Full Stack Engineer (Java + Angular)to design, develop, and ma

Senior Commissioning, Qualification & Validation (CQV) EngineerJob Title - Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

Manufacturing Technical Writer--EAMJob Title - Manufacturing Technical Writer--EAM

Eliassen GroupCompany Name - 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

IT Enterprise Architect with Life Science ExperienceJob Title - IT Enterprise Architect with Life Science Experience

K Source IncCompany Name - 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