jobs in newark, de, us

Wilmington, Delaware

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13d 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 RAVE Clinical Database Programmer

Remote or New Jersey

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13d ago

Job Description: The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution. Key Responsibilities:

Full-time

Senior Rave Clinical Database Programmer

Remote or New York, New York

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13d ago

Summary: The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution. Key Responsibilities: Serve as

Full-time

Senior SAS programmer (RWE)

Remote or New York, New York

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13d ago

Summary: The senior programmer position will be responsible for manipulating large databases and generating reports to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS and SQL programming skills and the ability to implement complex logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience building patient cohorts and evaluating patien

Full-time

RWE Programmer (SAS)

Remote or New Jersey

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13d ago

Job Summary: We are seeking an experienced Real World Evidence (RWE) Programmer with strong SAS, SQL, and R programming expertise to support observational research and healthcare data analytics initiatives for pharmaceutical and biotechnology clients. The ideal candidate will have hands-on experience working with large-scale healthcare claims and Electronic Health Record (EHR) databases, developing patient cohorts, and creating high-quality analysis datasets for real-world evidence studies. This

Full-time

CQV Engineer

Remote or New Jersey

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13d ago

Summary : This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manuf

Full-time

MODA Systems Analyst

Remote or New Jersey

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13d ago

Job Description: We are seeking a high-level Lab Systems Administrator for a fully remote position to execute administration, maintenance, and master data activities specifically for the MODA platform in support of the Massachusetts Biologics Operations (MBO) site. This role maintains system workflows, handles instrument interfaces, provides first-tier remote end-user support, and coordinates closely with Global system owners regarding system changes and communications. All requests, issues, and

Full-time

Medical Device V&V engineers

Remote or New Jersey

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13d ago

Summary: We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Roles & Responsibilities: Design Controls: Lead efforts to deve

Full-time

Senior Automation Engineer

Remote or New Jersey

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13d ago

Roles & Responsibilities: Role requires a senior level automation engineer comfortable operating independently while supporting others. No CSV authorship responsibility: CSV activities are supported indirectly through automation execution and issue resolution. DeltaV DCS automation experience in pharmaceutical / biopharma manufacturing Strong troubleshooting and problem solving skills in live manufacturing environments, including commissioning, issue triage, and rapid resolution under GMP constr

Full-time

Sterilization Engineer II

Remote or New Jersey

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13d ago

Summary: The Sterilization Engineer is responsible for intermediate activities related to Development Services product and process development, fabrication, and sterilization of materials as work order needs dictate. The ideal candidate should have 7+ years of relevant experience in sterilization engineering within pharmaceutical or medical device environments. Roles & Responsibilities: Turnover, controls, care, and custody from EPCM to client. Signature authority on equipment turnover. Fo

Full-time

Mechanical Engineer

Remote or New Jersey

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13d ago

Job Description: The successful candidate will be responsible for the design modification packages for mechanical systems and/or components for nuclear power plants. Requirements: Must have commercial nuclear and design modification package experience. Prefers candidates who have lead and driven the modification process. Bachelor of Science degree in Mechanical Engineering from ABET accredited school. 7-10+ years relevant work experience is considered necessary. Working knowledge of codes,

Full-time

AI Engineer - Clinical Data Science

Remote or New York, New York

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13d ago

Job Description: We are looking for an AI Engineer to join our Data Science team, building AI-powered solutions for clinical data processing and analysis within a major pharmaceutical organization. You will design, develop and deploy generative AI systems that automate clinical reporting workflows, extract intelligence from documents, and accelerate data-driven decision making. This is a hands-on engineering role - you'll be writing production code, not just building prototypes. Responsibilities

Full-time

CSV Engineer

Newark, Delaware

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13d ago

Job Summary: We are looking for a Computer System Validation (CSV) Engineer to support our client in Newark, DE. In this role, you will be responsible for ensuring that computerised systems used in regulated environments are validated and compliant with industry standards. You will work closely with IT, Quality, and business teams to support validation activities and maintain system compliance throughout its lifecycle. Roles & Responsibilities: Lead and support CSV activities for GxP systems, in

Full-time

jobs in Newark, DE, USA