jobs in dublin, ca, us

Dublin, California

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Today

Roles & Responsibilities: Act as technical lead for mechanical design within electromechanical medical device programs. Own the mechanical architecture and interfaces for electro-mechanical subsystems including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations. Lead end-to-end mechanical design activities from concept, feasibility, and prototyping to design freeze and production release. Translate user needs, system requirements, and electrical/software

Full-time

CSV Engineer

San Francisco, California

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Today

Roles & Responsibilities: Develop and implement validation strategies for computer systems and software applications. Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports. Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements. Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems. Conduct validation

Full-time

Validation Engineer

San Francisco, California

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Today

Responsibilities: Client is seeking validation consultants to support a 9-month minimum onsite project in South Carolina. The consultants will support validation execution and gap assessments tied to equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification. The project is being driven by audit findings and identified gaps in the site's validation program. The primary focus will be equipment validation, especially around

Full-time

Validation Engineer

San Jose, California

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Today

Summary: In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. You will work cross-functionally to ensure the products meet the highest quality standards. Roles & Responsibilities: Develop and execute validation plans and reports. Analyze data and troubleshoot process deviations. Ensure compliance with FDA regulations and ISO standards. Collaborate with Engineering an

Full-time

SAS Programmer

San Francisco, California

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Today

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 m

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

Senior SAS programmer (RWE)

Remote or New York, New York

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Today

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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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

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

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

CQV Engineer

San Francisco, California

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Today

Job Description: We are looking for CQV Engineers / System Owners to take ownership of specific process and utility systems within either the Bulk (Drug Substance) or Fill Finish (Drug Product) areas on a large-scale greenfield. This role focuses on system ownership across the full CQV lifecycle, from design review through to qualification and handover, ensuring all systems are delivered in line with GMP and project standards. Responsibilities: ct as System Owner for assigned equipment within B

Full-time

Process Development Engineer

San Francisco, California

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Today

Job Description: We are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design changes, and technology transfer within a regulated medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for manufacturability, assembly, scalability, and operat

Full-time

Validation Engineer

San Francisco, California

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Today

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

CSV Engineer

Redwood City, California

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Today

Summary: Our client is looking for an experienced and well-rounded CSV (Computer System Validation) Consultant to support multiple ongoing projects within a pharmaceutical environment. The ideal candidate must have hands-on experience with Veeva platforms and data migration projects in regulated pharma environments. Roles & Responsibilities: Validating Veeva platforms within a pharmaceutical company Developing UAT documents and writing test scripts Managing change controls including creation, e

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, 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

Senior Clinical Database Programmer

San Francisco, California

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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

jobs in Dublin, CA 94568, USA