jobs in dublin, ca, us

Remote or 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

SAS Programmer

Remote or 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

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

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

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

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

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

Mechanical Engineer

Remote or Phoenix, Arizona

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Today

Job Description: The Mechanical Engineer position is responsible for quality inspection and assurance across various commodities, including precision machined parts, stamping, cast machined, and electromechanical components. The role involves overseeing inspections at multiple stages such as raw material, machining, heat treatment, coating, and final inspection. The engineer will collaborate with various departments, including QA and product engineering, to ensure adherence to specifications an

Full-time

Process Development Engineer

Remote or Worcester, Massachusetts

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Today

Job Summary: 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 operational

Full-time

Process Engineer

Remote or Phoenix, Arizona

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Today

Job Description: Support the deployment of the MTO aspiration "to innovate to safely supply quality products and services competitively, faster, always". Responsible for providing advanced engineering design and start-up of GMP large molecule biologics manufacturing facility systems, and equipment. Provide integrated equipment, utility, and facility engineering expertise with an operational focus in support of technology transfer and manufacturing projects to support 'right first time' executio

Full-time

Validation Engineer

Remote or Springfield, Massachusetts

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Today

Job Description: Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. The ideal candidate will have direct validation engineering or CQV experience in a fast-paced GMP environment, with strong exposure to fill line qualificat

Full-time

Product Quality Engineer

Remote or Greenville, South Carolina

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Today

Job Description: We are seeking a Product Quality Engineer to ensure product quality throughout the entire product lifecycle, from design and development through manufacturing and post-market support. The ideal candidate will collaborate with cross-functional teams to establish quality requirements, drive continuous improvement, investigate product quality issues, and ensure compliance with industry and regulatory standards. This role is ideal for candidates with experience in medical devices,

Full-time

Commissioning & Qualification Engineer

Remote or Cincinnati, Ohio

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Today

Job Description: We are looking for an experienced Commissioning & Qualification (C&Q) Engineer to join our team in support of a major capital expansion project involving the installation of four new packaging lines. This is a hands-on C&Q role embedded within a pharmaceutical secondary and tertiary packaging operation for final drug product. This is not a validation role, we are looking for a true C&Q professional with deep expertise in equipment commissioning, system turnover, and manufacturin

Full-time

Lead Validation Engineer

Remote or New Jersey

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Today

Job Description: The Lead Validation Engineer leads GMP equipment installation, commissioning, and qualification projects supporting large-molecule biologics manufacturing. This role supports upstream and downstream processes and ensures projects are executed safely, on schedule, and in compliance with regulatory and quality requirements. Responsibilities: Lead end-to-end CQV execution for GMP equipment projects, managing activities from installation through IQ, OQ, and PQ for biologics manufact

Full-time

Senior Validation Engineer Consultant

Remote or Massachusetts

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Today

Job Description: Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible for executing IQ/OQ protocols, equipment verification, temperature mapping, SIP/CIP validation activities, deviation support, and ensuring compliance with GMP/GDP standards while collaborating with Engineering, QA, and Operations teams. Roles & Responsibilities: Execute Installation Q

Full-time

Process Validation Engineer

Remote or Indianapolis, Indiana

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Today

Job Description: We are seeking a Process Validation Engineer to support validation and qualification activities in a GMP-regulated manufacturing environment. The ideal candidate will have experience with process validation, equipment qualification, CSV, temperature mapping, and regulatory compliance. Responsibilities: Execute process validation and equipment qualification activities (IQ, OQ, PQ, PPQ). Develop, review, and maintain validation protocols and reports. Support Computer Systems Vali

Full-time

Process Engineer

Remote or Wilson, North Carolina

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Today

Full-time

Process Engineer

Remote or Raynham, Massachusetts

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Today

Roles & Responsibilities Write and execute validation protocols and reports (IQ, OQ, PQ). Develop and implement manufacturing processes, specifications, operator instructions, process studies, and production readiness activities. Conduct investigations, root cause analysis, problem solving, and prepare reports/presentations. Update procedures, manufacturing specifications, bills, routes, and travelers for product/process changes in PLM systems. Work with equipment manufacturers and distributors

Full-time

CQV Engineer

Remote or 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

Process Engineer 3

Remote or Wilson, North Carolina

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Today

Job Description: This position is to be located in Wilson, NC with domestic travel once a year. Support the deployment of the MTO aspiration "to innovate to safely supply quality products and services competitively, faster, always". Responsible for providing advanced engineering design and start-up of GMP large molecule biologics manufacturing facility systems, and equipment. Provide integrated equipment, utility, and facility engineering expertise with an operational focus in support of techno

Full-time

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jobs in Dublin, CA 94568, USA