jobs in summit, nj, us

Summit, New Jersey

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Today

Job Summary: The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment. The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal t

Full-time

CQV Engineer

Raritan, New Jersey

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Today

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 manufa

Full-time

Computer System Validation Engineer

Princeton, New Jersey

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Today

Job Description: In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency. Responsibilities: pply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training. Ensure system validation aligns with Data

Full-time

CQV Engineer

Remote or New Jersey

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Today

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

RWE Programmer (SAS)

Remote or New Jersey

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Today

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

Medical Device V&V engineers

Remote or New Jersey

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Today

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

MODA Systems Analyst

Remote or New Jersey

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Today

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

CSV Engineer

Raritan, New Jersey

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Today

Job Summary: Shop Floor CSV/CSA Lead/Engineer responsible for leading and executing validation deliverables across the lifecycle in regulated manufacturing and laboratory GMP/GLP environments. The role includes automation/controls validation, risk-based validation activities, audit readiness, data integrity compliance, and coordination with IT/OT teams for validated systems. Roles & Responsibilities: Lead and execute validation deliverables including risk assessment, validation planning, require

Full-time

Senior Automation Engineer

Remote or New Jersey

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Today

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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Today

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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Today

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

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Today

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

New Jersey

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Today

Summary : CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role will focus on validating ERP Master Data Governance processes and Data Lake platforms, ensuring compliance with regulatory requirements and data integrity standards. Roles & Responsibilities: Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems Support validation activities for E

Full-time

Senior Clinical Database Programmer

Edison, New Jersey

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Today

Job Description: Design, build, and configure clinical study databases in EDC/CDM platforms. Ensure systems meet client needs, follow GCDMP, support accurate data capture, workflows, edit checks, and integrations. Responsibilities: Lead Study Build / Database Configuration in EDC systems. Configure Edit Checks, Workflows, Validations. Gather & translate client requirements into solutions. Create Specifications / Test Cases / UAT Support. Support integrations & data transfers with vendors. Deliv

Full-time

Real-World Data Technical Analyst (RWD)

Rahway, New Jersey

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Today

Job Description: The Observational and Real-World Evidence (CORE) Real-World Data Analytics and Innovation (RDAI) team is seeking a Real-World Data (RWD) Technical Analyst to support real-world evidence generation and oncology outcomes research. This role will work with epidemiologists, biostatisticians, and scientists to conduct analyses using real-world data sources (claims, EHR/EMR, registries) and help develop advanced analytics tools and methodologies that accelerate observational research

Full-time

Process Engineer

Morristown, New Jersey

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Today

Responsibilities: Provide technical support for all products manufactured externally at third party contract manufacturers, North American locations. Frequent visits to third party sites for batch monitoring are required. ct as the technical expert on all product formulations, scale-up activity, process validation, equipment qualification, process related technical issues and investigations to ensure sites adhere to GMP and regulatory guidelines. Review and/or author technical protocols, reports

Full-time

jobs in Summit, NJ, USA