jobs in bothell, wa, us

Bothell, Washington

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Today

Job Summary: We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications. The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle. The primary responsibility is to ensure that validation activities supporting Manufacturing Exec

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 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

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

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

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

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

Digital Process Engineer

Remote or Cincinnati, Ohio

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Today

Roles & Responsibilities: We are seeking a highly collaborative Digital Process Engineer to support enterprise digital transformation initiatives focused on manufacturing, process engineering, and operational data optimization within a regulated environment. This role will combine process engineering knowledge with advanced digital and data capabilities to help modernize how process data is captured, analyzed, visualized, and leveraged across the organization. The ideal candidate will be digital

Full-time

Senior Validation Engineer / Project Lead (Medical Devices)

Remote or Salt Lake City, Utah

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Today

Summary: We are seeking a highly skilled R&D/Validation Engineer with mandatory experience in the Medical Devices domain. The ideal candidate will be responsible for planning, leading, and coordinating project execution and validation activities in strict alignment with ISO 13485 and ISO 14971 standards. This role requires a hands-on leader who can manage equipment, process, and product transfers while liaising with global teams and customers to ensure on-time delivery. Roles & Responsibilities

Full-time

Validation Engineer

Remote or Tucson, Arizona

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Today

Summary : We are seeking a proactive Validation Engineer with in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity. This is an on-site position that focuses on equipment validation. Roles & Responsibilities Develops, prepares, and executes IQ, OQ, and PQ protocols and reports for equipment/systems. Conducts risk assessments and develops qualification strategies for new and existing equipment/systems. n

Full-time

Validation Engineer

Remote or Tucson, Arizona

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Today

Job Description: We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably. FDA) to ensure compliance and drive operational integrity. This is an on-site position that focuses on equipment validation.Responsibilities: Develops, prepares, and executes IQ, OQ, and PQ protocols and reports for equipment/systems. Conducts risk assessments and develops qualification strategies for new and exist

Full-time

Senior Validation Engineer

Remote or Rock Hill, South Carolina

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Today

Job Description: 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 Qualification (IQ) and

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

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jobs in Bothell, WA, USA