21 CFR Part 11 jobs in Philadephia, PA

Remote

•

Today

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

Windchill Solution Architect/Senior Windchill PLM Consultant Medical Device Industry

Remote

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13d ago

Position Title: Windchill Solution Architect/Senior Windchill PLM Consultant Experience: 12+ Years Location: Flexible / Hybrid Domain: Medical Devices (additionally we can look at candidates from Life Sciences, Healthcare domain as well but preference shall be for candidates with Medical Devices domain background) Employment Type: Full Time / Contract Position Summary We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for a

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Third Party, Contract

80 - 90

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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28d ago

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing

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Contract

Depends on Experience

CSV Analyst

Lansdale, Pennsylvania

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5d ago

Job Description- Lead CSV compliance activities for capital and strategic projects.Must have worked in CSV in Manufacturing automation systems like DELTA V,PI Historian, PLC, LAB Automation Systems(any one pf the systems or all). Develop, Review and approve validation lifecycle deliverables in accordance with applicable SOPs and regulatory requirements, such as CFR 21 Part 11. Provide compliance guidance to project teams on SDLC, CSA, qualification, and validation approaches. Participate in pro

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Contract

50 - 51

CSV Analyst

Hybrid in Lansdale, Pennsylvania

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12d ago

Job Title- CSV Analyst Job Location - WestPoint, PA (Hybrid, must visit site 3 days a week) Job Description- Lead CSV compliance activities for capital and strategic projects. Must have worked in CSV in Manufacturing automation systems like DELTA V,PI Historian, PLC, LAB Automation Systems(any one pf the systems or all). Develop, Review and approve validation lifecycle deliverables in accordance with applicable SOPs and regulatory requirements, such as CFR 21 Part 11. Provide compliance guida

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Contract

Depends on Experience

Director, I&T Plasma Engineering

King of Prussia, Pennsylvania

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Today

The Director, I&T Plasma Engineering leads engineering and owns architecture governance across all CSL Plasma digital product domains. This role is internally focused on how the organization builds. Defining and owning the engineering standards, practices, and technology platform strategy that all development teams, managed service providers, and external vendors are held to. This role is also responsible for governing Artificial Intelligence (AI) and Generative AI in production across CSL Plasm

Full-time

Director, I&T Plasma Engineering

King of Prussia, Pennsylvania

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Today

Full-time

Senior Laboratory Systems Engineer

Exton, Pennsylvania

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Today

IntePros is seeking a Senior Laboratory Systems Engineer to support a major laboratory systems upgrade initiative focused on cloud-based data management, regulatory compliance, and software platform upgrades across analytical instruments. This role will provide hands-on IT infrastructure and laboratory systems support for the implementation of a secure, cloud-based environment supporting Agilent laboratory software applications across multiple analytical platforms. Key initiatives include implem

Full-time

USD 40.00 - 45.00 per hour

Senior Controls Engineer

Philadelphia, Pennsylvania

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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

PO Global Plasma Payments

King of Prussia, Pennsylvania

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Today

The Product Owner, Global Plasma Payments is accountable for the strategy, roadmap, and delivery of CSL Plasma\'s global donor payment platforms, including the Plasma US Payments (PUP) platform and European payment systems. This role drives the vision for how CSL Plasma compensates donors across markets, ensuring payment experiences are fast, accurate, secure, personalized, and compliant with regional financial regulations. The Product Owner partners with engineering teams, business stakeholder

Full-time

Veeva Migration Consultant

Remote

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4d ago

We are looking for 3 strong profiles with hands-on Veeva migration experience. We need candidates who can demonstrate: Hands-on migration of clinical trial data/documents to Veeva, including source-to-target mapping, transformation, cleansing, loading, and reconciliation.Experience with regulated clinical platforms such as CTMS/eTMF/EDC and migration controls covering audit trails, metadata, data integrity, and GxP/21 CFR Part 11 expectations.Experience executing mock/test/production migration c

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Contract, Third Party

Depends on Experience

Business Analyst - Veeva Migration

Remote

•

Today

Job Title : Business Analyst - Veeva Migration Job Location: REMOTE Must have hands-on Business Analyst experience in Veeva migration.Hands-on experience with Veeva CTMS, eTMF, and EDC is mandatory.Experience in migration requirements, source-to-target mapping, data validation, and reconciliation is preferred.Hands-on migration of clinical trial data/documents to Veeva, including source-to-target mapping, transformation, cleansing, loading, and reconciliation.Experience with regulated clinical

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Contract

50 - 60

Clinical Data Analyst

Remote or New Jersey

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7d ago

Key Responsibilities: Develop, maintain, and execute SAS programs to support external data transfers, including validation against vendor transfer specifications Generate and maintain Data Review Listings (DRLs) and Study Health Metrics (SHMs) in accordance with study timelines Perform peer review of DRLs and data reconciliation reports Monitor automated job logs and resolve issues as needed Retrieve and post external vendor data using sFTP/FTP clients and vendor portals Collaborate with data ma

Full-time

Validation SME

Remote

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7d ago

Validation SME- Remote Job Summary We are looking for an experienced Validation Subject Matter Expert (SME) with strong knowledge of pharmaceutical and life sciences validation processes, regulatory compliance, and quality systems. The candidate will provide technical expertise and leadership for validation activities across manufacturing, laboratory, utilities, and computerized systems. Key Responsibilities Lead and provide SME support for validation and qualification activities. Develop and

Full-time, Third Party

Depends on Experience

Clinical Trial Product Owner

Remote

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25d ago

We are hiring for a Product Owner. It s a long-term contract role // Fully Remote role. Title : Product Owner Work Schedule: Fully Remote role. Required Skills : Product Owner with Pharma or Clinical Trial Platform Please email me your resume at Role Overview The Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution. This role blends product owner discipline with deep

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Full-time

Depends on Experience

Windchill Solution Architect

Remote

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19d ago

Job Description: Summary Seeking an experienced Windchill PLM SME to assess the current PTC Windchill landscape and define the upgrade strategy and roadmap for Windchill 2027. Preference for candidates with a strong Medical Devices background; Life Sciences and Healthcare experience will also be considered. Responsibilities Assess existing Windchill configuration, customizations, workflows, data models, infrastructure, and integrations.Evaluate Windchill 2027 readiness, upgrade risks, technical

Contract

$100 - $130

Veeva CRM Techno-Functional Consultant

Remote

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5d ago

Veeva CRM Techno-Functional Consultant Job Summary We are seeking an experienced Veeva CRM Techno-Functional Consultant with strong expertise in Veeva CRM, Salesforce, and pharmaceutical commercial operations. The ideal candidate should have hands-on experience in Veeva CRM configuration, customization, integrations, business requirements gathering, and end-to-end implementation and support. Key Responsibilities Work closely with business stakeholders to gather, analyze, and translate business r

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Third Party, Contract

Depends on Experience

Cloud Engineer (AWS / Azure)

Remote

•

Today

3Core Systems, Inc is an SAP and Success Factors Partner with employees located across the United States. Our organization is dedicated to customer and employee satisfaction. We provide High Quality, Cost efficient and Competitive Solutions and Resources. 3Core Systems is looking for a Cloud Engineerfor one of our clients Remote Title: Cloud Engineer Duration: 12 Months Location: Remote Qualifications: The Cloud Engineer is responsible for designing, implementing, and maintaining secure, scal

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Contract

Depends on Experience

Trackwise Digital Support Lead

Remote

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6d ago

Job Position: Trackwise Digital Support Lead Job Location: Remote Job Duration: Fulltime Salary: $150K - $180K/Annum with benefits Job Description: Must Have Technical/Functional Skills: Strong relevant experience, including demonstrated L2/L3 support expertise for TrackWise / TrackWise Digital QMS in regulated life sciences or medical device environments.Hands-on expertise in TrackWise Digital support for global complaint handling, post-market support, complaints management and adverse event

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Full-time

Depends on Experience

Planisware PPM Administrator w/ Power BI

Remote

•

Today

Global PMO Systems Specialist Location: 100%Remote - working hours EST Contract Duration: 12 Months plus Start Date: ASAP Compensation: Very attractive, won't be a waste time to discuss it. About the Role Our client is seeking an experienced Global PMO Systems Specialist 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, go

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Contract

21 CFR Part 11 jobs in Philadelphia, PA, USA