21 CFR Part 11 jobs in Philadephia, PA

OT Solutions Architect – MES & SCADA (Application Architect – Operations Technology)

Remote

•

Yesterday

We are seeking an experienced OT Solutions Architect specializing in Manufacturing Execution Systems (MES) and Supervisory Control and Data Acquisition (SCADA) to design, support, and deliver manufacturing technology solutions across multiple manufacturing sites. The ideal candidate will provide IT-side solution architecture and technical governance for Sepasoft MES and Ignition SCADA platforms, ensuring secure, scalable, and reliable integration between Operational Technology (OT) and enterpris

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Contract, Third Party

Depends on Experience

Manufacturing Data Strategy & Architecture Consultant

Remote

•

20d ago

Job title: Manufacturing Data Strategy & Architecture Consultant Location: Remote Position Overview Seeking a senior Manufacturing Data Strategy & Architecture Consultant to support the development of a future-state data vision, strategy, and architecture roadmap. The ideal candidate will bring deep expertise in pharmaceutical manufacturing data ecosystems, industrial data architectures, contextualization, semantics, and GxP-regulated environments. This role will serve as a trusted advisor to Pf

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Full-time, Third Party

Depends on Experience

Senior Validation Engineer

Conshohocken, Pennsylvania

•

Today

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Primary Duties & Responsibilities: Support the computer system validation process by ensuring alignment o

Full-time

Computer System Validation Engineer

Wilmington, Delaware

•

2d 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

Senior Bioanalytics & Data Integration Project Manager

West Point, Pennsylvania

•

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

Bioanalytics & Data Integration Project Manager

West Point, Pennsylvania

•

Today

Full-time

Associate Director, Quality (Validation and Data Integrity)

Philadelphia, Pennsylvania

•

Today

Description: The Company: This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive,

Full-time

Senior Controls Engineer

Philadelphia, Pennsylvania

•

Today

Wunderlich-Malec Engineering has a Senior Controls Engineer opportunity available in Philadelphia, PA. This person will play a critical role in designing and implementing advanced Emerson DeltaV and/or Rockwell automation solutions for the Life Sciences industry. Working within a dynamic system integration environment, you will be part of a team responsible for delivering high-quality, fit-for-purpose, regulatory-compliant automation that supports biopharmaceutical and small molecule API manufac

Full-time

USD 110,000.00 - 160,000.00 per year

SAP Validation

Remote

•

11d 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

Sr Technical Writer

Remote

•

5d ago

Hi, Hope you are doing well. Job Title: Sr IT Technical Writer Location: Remote Duration:12+ Months Job Description: We areseeking a Senior IT Technical Writer with 10+ years of experience to support technical documentation initiatives within a Bio-Pharma/Life Sciences environment. The consultant will work closely with IT, engineering, application, infrastructure, quality, validation, and business teams to develop accurate and compliant documentation for regulated systems. The role involves cr

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Contract

Depends on Experience

OT Solutions Architect – MES & SCADA

Remote

•

Yesterday

OT Solutions Architect MES & SCADALocation: USA Remote Role: Application Architect Operations Technology Job SummaryWe are seeking an experienced OT Solutions Architect to design, implement, and govern Manufacturing Execution Systems (MES) and Supervisory Control and Data Acquisition (SCADA) solutions across manufacturing environments. The ideal candidate will have strong expertise in Ignition SCADA, Sepasoft MES, IT/OT integration, industrial cybersecurity, and enterprise architecture. The c

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Third Party, Contract

Depends on Experience

OT Solution Architect (MES/SCADA) -- C2C/W2 -- Remote

Remote

•

Yesterday

Role: OT Solution Architect (MES/SCADA) Location: Remote Job Responsibilities:Work with ITside solution architecture for MES Sepasoft and SCADA Ignition systems across manufacturing sitesEnsure MES and SCADA solutions align with STERIS ITOT architecture, cybersecurity, and infrastructure standardsDevelop and maintain the enterprise MES/SCADA deployment playbook, including architecture standards, module selection criteria, implementation methodologies, and governance processes for Ignition an

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Third Party, Contract

Depends on Experience

Product Owner

Remote

•

5d ago

Iris's direct client, a leader in Healthcare services, looking to hire a strong Product Owner for a Long-Term Contractual role Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, Clinical Trial Platform Job Description: Product Manager Clinical Trial Platform Role Overview The Product Manager for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end-to-end clinical trial executio

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Contract

Depends on Experience

Senior Consultant - GxP & Clinical Quality Assurance

Remote

•

26d ago

Arthur Lawrence is looking for a Senior Consultant - GxP & Clinical Quality Assurance one our clients project based on Remote. Please find the job description below and send us your updated resume if interested: Must-Have Skills:10+ years of GxP Quality Assurance experience in biopharma, biotech, or medical devices, including 3+ years at Senior Manager or Director level. Hands-on expertise in Google Cloud Platform site audits, CRO governance, TMF management, and FDA BIMO inspections. Strong ex

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Contract, Third Party

$70 - $75

SENIOR PRODUCT OWNER

Remote

•

2d ago

Hi, Greetings from Iflowsoft Solutions Inc Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, with Clinical Trial Platform experience-- MUST Job Description: Product Manager Clinical Trial Platform Required Qualifications Bachelors degree in life sciences, engineering, product management, or related field. 12+ years of product management experience, ideally within clinical trials, healthcare technology, or regulated SaaS platforms. Strong understanding of

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Full-time

Depends on Experience

Planisware PPM Administrator w/ Power BI

Remote

•

Today

Systems / Data Analyst Location: Remote (Easter Time Zone) Contract Duration: 12 Months plus Start Date: ASAP About the Role Our client is seeking an experienced Systems / Data Analyst to support its Technical Services organization within the pharmaceutical and life sciences industry. This position will serve as the primary Planisware System Administrator, with responsibility for platform configuration, governance, user access, and ongoing enhancements. The Systems / Data Analyst will also d

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Contract

Sr SampleManager Implementation Engineer

Remote or Indiana

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior SampleManager LIMS Implementation Engineer How will you make an impact? As a Senior SampleManager LIMS Implementation Engineer, you will be a technical expert responsible for the configuration, implementation, integration, and deployment of Thermo Scientific SampleManager LIMS solutions. This role is highly hands-on and focused on translating defined laboratory processes and solution designs into robus

Full-time

USD 93,800.00 - 140,675.00 per year

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

Solutions Engineer, Life Sciences

Remote

•

29d ago

Who we are At Domino, we build software that helps the largest, AI-driven organizations build and operate advanced data science and AI solutions at scale. Our platform integrates a streamlined model development environment, MLOps capabilities, and novel features for collaboration, reuse, and reproducibility - all of which make data science teams more productive, reduce time to value, and ensure compliance. Our customers - like Johnson & Johnson, GSK, Bristol Myers, UBS, FINRA and the US Navy -

Full-time

USD 160,000.00 - 230,000.00 per year

Senior Manager, Global Digital & Technology System Ownership

Remote

•

Today

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. BeOne is a global biopharmaceutical company dedicated to the discovery and development of innovative drug therapies for the treatment of cancer. At BeOne we believe that access to life-changin

Full-time

USD 136,900.00 - 181,900.00 per year

21 CFR Part 11 jobs in Philadelphia, PA, USA