FDA Jobs in Pennsylvania

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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 9 hours 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 8 days ago | Updated 8 hours 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 24 days ago | Updated 10 hours ago

Lab Computing Analyst

Pyramid Consulting, Inc.

•

Lansdale, Pennsylvania, USA

Contract

Immediate need for a talented Lab Computing Analyst. This is a 06+months contract opportunity with long-term potential and is located in Lansdale, PA(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 25-72571 Pay Range: $32 - $33.75/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Shift timings-40 HR/wk, M-F,
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Posted 8 days ago

PTC Arena Consultant

Teknikoz

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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 8 hours ago | Updated 7 hours ago

Virology Deviation Management Specialist

Zachary Piper Solutions, LLC

•

West Point, Pennsylvania, USA

Full-time

Piper Companies is looking for a Virology Deviation Management Specialist for a leading pharmaceutical manufacturer in West Point, PA. Responsibilities: Conduct microbiological testing within investigations to prove root causeRecommend corrective and preventive actions (CAPAs)Conduct deviation OOS investigations related to testing within pharmaceutical manufacturing Qualifications: 2+ years of experience within GMP/FDA regulated environmentFamiliarity with virology Strong background in pharm
Posted 14 days ago | Updated 2 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 2 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

•

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 3 days ago | Updated 2 hours 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 3 days ago | Updated 11 hours ago

Mechanical & Biomedical Engineer

Katalyst Healthcares and Lifesciences

•

Pittsburgh, Pennsylvania, 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 4 hours ago

Oracle Field Service Cloud Consultant

Prutech Solutions

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Remote

Full-time

Oracle Field Service Cloud Consultant Full Time Job Duties and Responsibilities: Conduct thorough needs assessments to understand client requirements and identify opportunities for improvement.Design, configure, and implement Oracle's Field Service applications, including MES, FSM, SCM, and Quality Management solutions.Customize software to fit unique business processes and workflows.Integrate Oracle solutions with other systems and applications used by clients.Provide comprehensive training an
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Posted 6 hours ago | Updated 6 hours ago

Remote Senior QA Test Manger/QA Leader with Strong Healthcare Domain

Infinite Computer Solutions (ICS)

•

Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Descriptions : We are looking for an experienced Senior QA Healthcare Manager/QA Leader 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: Lead and manage the QA t
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Posted 3 days ago

Senior Expert Physicist

Spar Information Systems

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US

Third Party, Contract

Looking for a Senior-Level Expert-preferably a scientist or physicist-with hands-on experience designing, developing, and troubleshooting magnetic tracking systems, especially in medical device or similar precision environments. Key Requirements: Domain-Specific Expertise Must have direct experience building and shipping magnetic tracking solutions-ideally used in catheter navigation, cardiac, gastrointestinal, or surgical tracking systems. Should be deeply familiar with electromagnetic field be
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Posted 6 days ago | Updated 1 hour ago

Offshore Remote role-SAP FunctionalSD/SM (Service Management)

Connexions Data Inc

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Remote

Contract

SAP FunctionalSD/SM duration: 6 months to start Requirement for Functional SD/SM position Position level: Support Exp: ECC and S4 HANA Support 8 -10 years of hands-on experience with SAP ECC & S/4HANA in SD and SM modules.Strong expertise in Sales and Distribution, Logistics Execution, In-House Service, Customer Service, Samples, Rentals.Hands-on experience with Sales Orders, Delivery, Service orders, Service Notifications, Equipment master.Experience integrating SAP SM/SD with MM/ IM/WM, PP, C
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Posted 1 day ago | Updated 1 day 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 22 days ago | Updated 4 hours ago

Virology Deviation Management Specialist

Zachary Piper Solutions, LLC

•

West Point, Pennsylvania, USA

Full-time

Piper Companies is looking for a Virology Deviation Management Specialist for a leading pharmaceutical manufacturer in West Point, PA. Responsibilities: Conduct deviation management supporting a Virology quality control team Conduct technical writing of deviation investigation results and initiate CAPAs Fully support all aspects of assigned projects and run the business activities, including but not limited to: participate in decision making, leading laboratory investigations, issue ident
Posted 38 days ago | Updated 2 hours ago

Commissioning & Qualification (C&Q) Engineer

Katalyst Healthcares and Lifesciences

•

Harrisburg, Pennsylvania, USA

Full-time

Responsibilities: Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities. Perform system startup, debugging, and initial testing of process and utility systems. Ensure that systems are installed and operating according to design specifications. Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning. Review and verify system documentation, such as P&IDs, wiring diagrams, and datashee
Posted 22 days ago | Updated 4 hours 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 6 days ago | Updated 2 hours ago

Principal Product Security Engineer (REMOTE)

Stryker

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Remote or Portage, Michigan, USA

Full-time

Work Flexibility: Remote Product Security is driven to make healthcare better by ensuring that Stryker designs, develops, and maintains industry leading cyber secure products for our customers. We are seeking a highly skilled Secure Product Lifecycle Expert to ensure the security of our medical devices across their entire lifecycle. This role is critical in embedding robust security practices into our software development lifecycle (SDL), overseeing post-market security management, and integrat
Posted 4 days ago | Updated 4 hours ago