FDA Jobs in Philadephia, PA

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Regulatory affairs - CMC Manager

Sureminds Solutions

•

Remote

Full-time

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 submissions, including global supplements/variations and responses to health authority queries. 2. Prep
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Posted 2 days ago

SAP Plant Maintenance (SAP PM)

IT Resonance Inc.

•

Remote

Contract, Third Party

SAP Plant Maintenance (SAP PM) 12 months Remote with travel to onsite (Chicago IL) Must have food & beverage manufacturing or consumer packaged goods industry experience Solid/Strong comm skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards Stephen DJA stephen at itresonance dot com
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Posted 16 days 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 25 days ago | Updated moments ago

Systems Engineer

Mindlance

•

Remote

Contract

Job Description: Must-Haves: 1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards. 3. Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability
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Posted 60+ days ago | Updated 1 day ago

Consultant, XRPD for Solid Oral dosage, GI

Eliassen Group

•

Anywhere, US

Contract

Description: *Remote role* Our F500 Pharma Client is seeking a consultant with strong technical XRPD expertise in solid oral dosage tablet for NDA readiness. We can facilitate w2 and corp-to-corp consultants. 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: $190 - $200 / hr. w2 Experience Requirements: Pharmaceutical Drug Development Experience Solid Oral Dosage Experience Str
Posted 50 days ago | Updated moments 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 21 hours ago | Updated 10 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 4 days ago | Updated 10 hours ago

Supplier Quality Engineer - Pharma

Zachary Piper Solutions, LLC

•

Malvern, Pennsylvania, USA

Full-time

Piper Companies is seeking a Supplier Quality Consultant in Malvern, PA to support a global pharmaceutical company with a remediation project and liaise with suppliers. Responsibilities of the Supplier Quality Engineer Responsible for establishing quality expectations of suppliers, and supplier process changes Evaluate potential and existing suppliers to ensure they meet quality standards and specifications. Develop and maintain supplier evaluation and selection processes. Conduct supplier au
Posted 4 days ago | Updated 10 hours ago

Pharmaceutical Equipment Commissioning & Qualification Engineer

Zachary Piper Solutions, LLC

•

Hopewell Township, New Jersey, USA

Full-time

Piper Companies is currently seeking a Pharmaceutical Equipment Commissioning & Qualification Engineer for an opportunity in Titusville, New Jersey or Raritan, New Jersey , to join a global pharmaceutical company. Responsibilities: Maintain, calibrate, qualify and validate equipment used in the production, testing and packaging of pharmaceutical products Develop, execute, and document equipment qualification protocols and test plans in accordance with cGMP regulations and industry standards C
Posted 4 days ago | Updated 10 hours ago

SAP QM Solution Architect - S4 HANA with EWM.

ArkInfoCubes

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Exton, Pennsylvania, USA

Contract

Role: SAP QM Solution Architect - S4 HANA with EWM. Location: Extron, PA Experience: 13+ Years Must Have Skills: QM/ Quality Management, S4 HANA, SHOP FLOOR /EWM Summary: The Senior Solution Architect, SAP QM requires in-depth knowledge and experience and is accountable for collaborating with the D&T team in various locations to define, deliver and support IT enabled business solutions for the Quality Management. This role will also help determine business needs and design & deliver technical so
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Posted 3 days ago

SAP Solution Architect (SAP PP and SAP QM)

GSSR

•

Exton, Pennsylvania, USA

Contract

We are looking for senior SAP Solutions Architects. Candidates need to have advanced configuration skills with SAP PP and QM. (PP-primary; QM secondary). Candidate should also have S4 Hana and ideally some EWM skills. In office at Exton 3 days a week. There may be occasional travel to Arizona down the road. AZ travel would be covered and not too much expected. Essential Duties and Responsibilities: Possesses solid understanding of overall vision and business needs and utilize specialized ex
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Posted 32 days ago | Updated 5 days ago

Solution Architect with Pharma & Regulatory Experience

The Dignify Solutions, LLC

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Remote or Raritan, New Jersey, USA

Third Party, Contract

Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance. Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases. Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways. Design and optimize Cloud-native data pipelines for r
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Posted 9 days ago | Updated moments ago

Sr Full Stack Engineer

Pinnacle Software Solutions

•

Remote

Contract

KFORCE URGENT REQUIREMENT Looking for candidates regarding the following: POSITION Sr Full Stack Engineer LOCATION Remote DURATION 6+ months INTERVIEW TYPE Video VISA RESTRICTIONS None REQUIRED SKILLS 5+ years of experience working in a SaaS-based product development environment or FDA-regulated medical device environmentExperience with programming languages Java, JavaScript, and SQLMust have SaFE Agile framework experienceSpring BootAngular
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Posted 1 day ago | Updated 1 day ago

SAP Plant Maintenance Consultant

IT Resonance Inc.

•

Remote

Third Party, Contract

Hi, Here is an Remote Contract Job opportunity for below position. Role: SAP Plant Maintenance (PM) Consultant Location: IL, Remote + (Occasional Travel) Contract Duration: 12+ Months Experience: 10 + Year skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards, Nirmal Kumar Phone:- Email:-
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Posted 16 days ago

Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Zachary Piper Solutions, LLC

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Remote or Atlanta, Georgia, USA

Full-time

Piper Companies is Senior Manager for Regulatory Affairs Labeling Strategy to join the team a global biopharmaceutical company focused in neurology and immunology. In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and commercialization. This preferred candidate will be located in the Atlanta, GA or Raleigh, NC regions, however candidates outside of these regions will be considered as well. Responsibilities of
Posted 1 day ago | Updated 10 hours ago

Engineer II

Parker Hannifin

•

Hatfield, Pennsylvania, USA

Full-time

Org Marketing Statement Position Summary The Precision Fluidics Division of Parker Hannifin Corporation is a leading global supplier of Nitrous Oxide Delivery systems used in the dental and medical professions. We also produce miniature fluidic components and system solutions integral to medical and analytical instrumentation. This position focuses on our Nitrous Oxide delivery systems and associated products, enhancing existing products, and supporting lifecycle management of those products. Th
Posted 31 days ago | Updated moments ago

Sr. Full Stack Engineer (Remote)

Pinnacle Software Solutions

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Remote

Contract

Position: Sr. Full Stack Engineer Location: Remote Duration: 6+ Months (Contract) Job Overview: We are seeking a Sr. Full Stack Engineer to join our growing team and contribute to the development of cutting-edge SaaS solutions. This is a fully remote role ideal for experienced engineers with a strong background in Java, JavaScript, and SQL, and who are comfortable working in fast-paced, Agile-driven environments. Candidates with experience in FDA-regulated medical device development or SaaS prod
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Posted 1 day ago | Updated 1 day ago

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
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Posted 2 days ago

Sr Appian Developer

Techwizens LLC

•

Remote

Contract

Job Description- Lead and mentor development team members on best practices. - Develop applications using Appian and integrate with COTS products. - Implement Appian and web-based applications. - Create design documents, target state diagrams, and instructions. - Build Appian applications and integration components in Java. - Provide technical guidance to mid-level developers as needed. - Participate in meetings for design reviews and troubleshooting. - Collaborate with release manager on deploy
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Posted 4 days ago

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
Posted 60+ days ago | Updated 10 hours ago