FDA Jobs in Philadephia, PA

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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

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

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,

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

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)

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

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

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

Senior Mechanical Engineer/Technical Lead (Healthcare & Pharmaceutical)

Jobot

Philadelphia, Pennsylvania, USA

Full-time

Sr Mechanical Engineer/Technical Lead (Healthcare/Pharma) - REMOTE This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $125,000 - $150,000 per year A bit about us: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing and fire protecti

Lab Computing Analyst

Russell, Tobin & Associates

Lansdale, Pennsylvania, USA

Contract

The Science Team at Russell Tobin & Associates supports the Pharmaceutical Organization team that has an opening for Lab Computing Analyst in Lansdale, PA! Additional Details: Contract Length: 6 months (Contract-to-Hire) Pay range: $30 to $33/hour on W2 Position Overview: The Lab Computing Analyst will provide advanced technical support for laboratory IT environments integrated with scientific instrumentation. This includes implementing, monitoring, and troubleshooting lab computing systems and

Quality Engineer

Juno Search Partners

Horsham, Pennsylvania, USA

Full-time

Position SummaryThe Quality Engineer supports all departmental activities with a focus on compliance, continuous improvement, and quality-by-design. Key responsibilities include documenting system enhancements for product and service compliance, partnering with customers and production teams, and driving corrective actions and ongoing improvements throughout the product lifecycle. This is a fully on-site role based in Horsham, PA. Essential Duties & Responsibilities(Responsibilities include, but

Senior Engineer, Packaging Engineer

Johnson & Johnson

Malvern, 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

Site Automation Project Engineer

Apex Systems

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

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

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: Active

Drug Safety Scientist

Sunrise Systems, Inc.

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

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

Senior Expert Physicist

Spar Information Systems

US

Contract, Third Party

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

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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

Oracle Field Service Cloud Consultant

Prutech Solutions

Remote

Contract

Job Title: Oracle Field Service Cloud Consultant Duration: Full Time / Contract Location : Remote Required Skills/Experience: Bachelors degree in computer science, Information Technology, Engineering, or a related field.5+ years of experience in implementing and supporting Oracle's Field Service solutions.Strong understanding of and field service processes and best practices.Proven expertise in Oracle's E-Business Suite, Cloud, or other relevant Oracle products.Excellent analytical and problem-