Gxp jobs in philadelphia, pa

Technical Project Manager - SaMD / GxP Validation

Remote

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Today

Technical Project Manager - SaMD / GxP Validation. We need an independent, Quality-first project manager to drive an imaging algorithm Software as a Medical Device (SaMD) program in R&D IT toward a trial launch targeted for Q3. You will run the plan, clear blockers and own the validation documentation, all within a regulated Quality Management System (QMS). This is a technology role, not clinical operations, and we want someone who can start delivering in week one. Engagement 12-month contract

Contract

$60.00 - $80.00

GxP Systems and Support Administrator

Remote

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Computer System Validation Engineer

Wilmington, Delaware

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14d ago

Roles & Responsibilities : 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes uthoring of URS/FS, protocols, final reports, validation plan/report High-level understanding of Veeva Vault suits Risk-based testing aligned to CSA fundamentals High-level understanding of Biostatistics, Clinical, Discovery, Med

Full-time

Associate Director of Engineering

Philadelphia, Pennsylvania

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Today

Introduction to the Role Are you ready to lead an engineering team that keeps critical manufacturing running flawlessly while modernizing how we deliver life-changing medicines? This role anchors a high-performing group at our Philadelphia site, resolving complex process issues in real time and driving strategic improvements across automation, aseptic manufacturing, packaging, and project execution. Your work will help ensure reliable supply, faster scale-up, and the quality our patients depend

Full-time

Senior Bioanalytics & Data Integration Project Manager

West Point, Pennsylvania

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Today

Company Description The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. Eurofins Scientific is an international life sciences company, prov

Full-time

SAP Validation

Remote

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24d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

Associate Automation Engineer - 2nd Shift

King of Prussia, Pennsylvania

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Today

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021. We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across o

Full-time

Senior Bioprocess Engineer

King of Prussia, Pennsylvania

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Today

The Manufacturing Science and Technology (MSAT) organization is a site-based team, providing technical support to ensure Upper Merion Biopharm site goals and objectives areachieved. The primary objective role of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team is also responsible for delivering continuous improvements to the existing supply chains supported by UM Biopharm and working with global MSAT to execute tec

Full-time

Business Systems Analyst III

Remote

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6d ago

Business Systems Analyst LMS Transformation & SAP SuccessFactors Learning Migration Sumtotal LMS experience is required. 12 month remote contract. $40 an hour w2. No C2C or 1099 at this time. EST or CST candidates preferredPosition SummaryMilestone is seeking an experienced Business Systems Analyst (BSA ) to support the enterprise Learning Management System (LMS) transformation initiative, including the migration from SumTotal LMS to SAP SuccessFactors Learning. The BSA will serve as the l

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

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6d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

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6d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

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6d ago

Business Systems Analyst LMS Transformation & SAP SuccessFactors Learning Migration12 month remote project - Candidates should sit in CST or EST time zone. $40 an hour w2. No Corp to Corp or 1099 support at this time. Position SummaryMilestone is seeking an experienced Business Systems Analyst (BSA ) to support the enterprise Learning Management System (LMS) transformation initiative, including the migration from SumTotal LMS to SAP SuccessFactors Learning. The BSA will serve as the liaison

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Contract

Depends on Experience

Business Systems Analyst III

Remote

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6d ago

Easy Apply

Contract

Depends on Experience

Sr. IT/OT Infrastructure Engineer - Manufacturing Digitalization at Cincinnati, OH (Remote)

Remote

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9d ago

Position: Senior IT/OT Infrastructure Engineer - Manufacturing Digitalization Location: Cincinnati, OH (Remote) Duration: 3+ Months Job Description: We are seeking an experienced Senior IT/OT Infrastructure Engineer Manufacturing Digitalization to support manufacturing equipment digitalization, network connectivity, Data Integrity (DI) upgrades, MERA network onboarding, and VxRail infrastructure within a regulated manufacturing environment. The role will provide hands-on IT/OT infras

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Contract, Third Party

Depends on Experience

CSA/CSV Validation Consultant

Remote or Arlington, Virginia

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Yesterday

Role - CSA/CSV Validation Consultant Remote Skills & Experience Required: empower or similar HPLC software Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain Familiarity with QMS processes including deviation management, CAPA, and change control. Strong command of CSA (Computer Software Assurance) principles Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+). Proven ability to write and manage valida

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Contract

Principal (Senior Director), Commercial Enterprise AI Product Mgmt. - E2E Marketing Enablement

Philadelphia, Pennsylvania

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Today

Business Introduction GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver 40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centered on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems. Our diverse portfolio consists o

Full-time

USD 195,525.00 - 325,875.00 per year

SAP Master Data Analyst (Hybrid) (No Corp to Corp or H-1B)

Hybrid in Malvern, Pennsylvania

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Today

Please note this position is a 6 Month Contract and is Hybrid (3 days Onsite in Malvern, PA). No Corp to Corp or H-1B Top Skills: Must have a Bachelors degree, required Must have SAP Master Data Management experience Basic maintenance experience Must have 3-4 years of experience SAP, required Master Data experience, required Experience in Manufacturing Master Data, highly preferred Should have Pharma background, preferred Experience working in Production Modules (SAP EP) Minimum Qualifi

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Contract

Depends on Experience

Bioanalytics & Data Integration Project Manager

West Point, Pennsylvania

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Today

Full-time

Loftware Spectrum Technical Lead

Remote

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3d ago

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

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Contract, Third Party

Depends on Experience

Principal (Senior Director), Commercial Enterprise AI Product Mgmt., Field Force Effectiveness

Philadelphia, Pennsylvania

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Today

Full-time

USD 195,525.00 - 325,875.00 per year

Gxp jobs in Philadelphia, PA, USA