fda Jobs in philadephia, pa

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MES Consultant Remote Location

Sierra Business Solution LLC

Remote

Contract, Third Party

MES Functional Consultant Location: Boston, MA Skill: POMSnet, PAS-X Role Description: ? 3-5 years of experience providing IT support for LIMS systems in a pharmaceutical, biotech, or laboratory setting. ? Experience with LabVantage LIMS is strongly preferred experience with LabWare LIMS also considered. ? Strong understanding of laboratory processes, sample management, and analytical workflows. ? Experience with LIMS system configuration, master data updates, and user management. ? Familiarity

Regulatory affairs - CMC Manager

Sureminds Solutions

Remote

Contract

Title : Regulatory affairs - CMC Manager Location: Remote This will be 100% remote in the US only PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product su

Head of Machine Learning (VP Level)

Penn Medicine

Philadelphia, Pennsylvania, USA

Full-time

Description Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines. Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our e

Computer System Validation Specialist

SGS Consulting

Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r

Clinical Research Associate (CRA)

Zachary Piper Solutions, LLC

Remote

Full-time

Piper Companies is seeking a Clinical Research Associate (CRA) with experience in Oncology clinical trials to join a reputable clinical research organization. This is a full-time/permanent opportunity. Some travel is required (regionally, about 8-10 days out of the month). Candidates must be located in CST or PST in one of the following states: WY, CO, KS, WI, IN, OH, MN, MO, IL, MI, KY, AR, CA, OR, WA, NV, UT, AZ. Responsibilities of the Senior Clinical Research Associate (CRA): Perform site s

Appian Developer - Remote!

General Dynamics

Remote

Full-time

Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Development 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 a

Sr. R&D Engineer

Medtronic

Remote or Irvine, California, USA

Full-time

We anticipate the application window for this opening will close on - 24 Jun 2025 Position Description: Sr. R&D Engineer for Covidien, LP (a Medtronic company) located in Irvine, CA. Multiple positions available. Responsible for providing R&D and quality engineering support to ensure the successful development of Medtronic Neurovascular devices, design transfers, scale-up and ongoing operational support; work with Design and Quality control of Class II and Class medical devices (bare-metal or

UX Writer

Beacon Systems, Inc

Remote

Contract, Third Party

About Beacon Systems, Inc Beacon 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. Position Title: Hybrid UX Designer / UX Writer Duration: Long Term Location: Remote- Orlando,

MES Consultant

BOTG LLC

Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact

Clinical Research Associate

Zachary Piper Solutions, LLC

Remote

Full-time

Piper Companies is seeking a Clinical Research Associate (CRA) with experience in Oncology clinical trials to join a reputable clinical research organization. This is a full-time/permanent opportunity. Some travel is required (regionally, about 8-10 days out of the month). Candidates must be located in CST or PST in one of the following states: WY, CO, KS, WI, IN, OH, MN, MO, IL, MI, KY, AR, CA, OR, WA, NV, UT, AZ. Responsibilities of the Senior Clinical Research Associate (CRA): Perform site s

Senior UX Designer (Hospitality, Travel, or Entertainment)

Beacon Systems, Inc

Remote

Third Party, Contract

About Beacon Systems, Inc Beacon 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. Position: Senior UX Designer Location: Remote - Orlando FL Duration: Long Term Summary: We are

CSV LEAD CONSULTANT

Shrive Technologies LLC

Remote

Contract, Third Party

Mandatory Skills CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ), Veeva, Argus, Defect Tracking Tools_JIRA 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform documentprocess Compliance Ana

Senior UX Designer

Beacon Systems, Inc

Remote

Contract

Beacon 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 Senior UX Designer - Remote Request you to make sure your updated Resume highlights all the below-me

Senior Appian Developer

Next Gen Software Solutions LLC

Remote

Contract

Job Title: Senior Appian Developer Location: Silver Spring, MD (Remote Position) Type: Contract (W2 through Next Gen Software Solutions LLC only No C2C) Duration: 12+ Months (Long-term) Pay Rate: $53 - $58/hour (W2) Note: Candidates must have an FDA Public Trust badge to qualify. Job Description Are you an experienced Appian Developer looking for a long-term opportunity to work on cutting-edge projects in a remote environment? Join Next Gen Software Solutions LLC as a Senior Appian Developer

SAP OPAL Label Consultant

Stefanini

Rome, Lazio, Italy

Contract

Stefanini Group is looking for a SAP OPAL Label Consultant for a globally recognized company! For interested applicants, click the apply button or you may reach out Micah Andres at / for faster processing. Thank you! Job Title: SAP OPal Label Consultant Job Description: We are seeking a skilled SAP OPal (One Platform for All Labels) Label Consultant to join our team. The ideal candidate will be responsible for designing, configuring, and implementing labeling solutions within the SAP environment

R&D Engineer

Medtronic

Remote or Fort Worth, Texas, USA

Full-time

We anticipate the application window for this opening will close on - 5 Jun 2025 Position Description: R&D Engineer for Medtronic, Inc located in Fort Worth, TX. Support the Design and development of mechanical and electromechanical devices for Class II and Class medical devices. Perform or develop product verification and validation, test fixtures, test protocols, data acquisition, test methodologies, analyze test data and author test reports in compliance with design control requirements. Cr

Senior Reg Ops Specialist SME

LMI Government Consulting (Logistics Management In

Remote

Contract

Overview LMI is seeking a Senior Reg Ops Specialist SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates w

AI Engineer

Thermo Fisher Scientific

Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as an AI Engineer to implement innovative AI and ML methods for our GxP Quality Management System. Key Responsibilities: Build AI Solutions: Develop predictive models, anomaly detection systems, and LLMs to optimize QMS performance.Improve GenAI and LLMs: Apply Generative AI techniques and LLMs to automate and improve tasks like quality events analysis, document reviews, and complaint management.Work wit

Sr. Reliability Engineer

Medtronic

Remote or North Haven, Connecticut, USA

Full-time

We anticipate the application window for this opening will close on - 7 May 2025 Position Description: Sr. Reliability Engineer for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for development of reliability testing methodologies for electrical and mechanical components and subsystems, test methods, and validation activities to meet requirements. Interface with cross-functional group members, various suppliers, and test laboratories. Perform data analysis using sta

Systems Storage Administrator

Peraton

Remote

Full-time

Responsibilities We are Hiring! Our FDA program is looking for a Storage Administrator. This qualified individual will join our team of highly performing technicians.This position is remote anywhere within the US. What You'll Do: The Storage admin is responsible for managing and maintaining data storage infrastructure.Ensuring data availability, security and performance. Operate, maintain, manage, tune, configure, troubleshoot, and patch.Upgrade all Storage Area Network (SAN)/Network Attached S