jobs in boulder, co, us

Boulder, Colorado

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Today

Job Description: We are seeking an experienced Validation Engineer with strong hands-on experience qualifying and validating pharmaceutical manufacturing equipment, specifically automated Parts Washers. Key Responsibilities: Execute validation and qualification activities for automated Parts Washers. Develop, review, and execute IQ/OQ/PQ protocols and reports. Support FAT/SAT, commissioning, and equipment qualification. Review URS, FS, DS, P&IDs, equipment specifications, and related documentati

Full-time

Senior CSV Engineer

Boulder, Colorado

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Today

Job Description: The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on

Full-time

Scientist - Machine Learning AI

Remote or New Jersey

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Today

Key Responsibilities: Develop and apply machine-learning and statistical approaches to protein structure, phenotypic, and other multimodal biological datasets. Curate, harmonize, and quality-control structured and unstructured data from internal and external sources. Build reproducible computational workflows for feature generation, model training, validation, and performance evaluation. Integrate protein structural representations with phenotypic and other biological data to generate testable h

Full-time

Healthcare Clinical Data Analyst

Remote or New York, New York

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Today

Summary: As a Data Analyst you will be a part of an Agile team to build healthcare applications and implement new features while adhering to the best coding development standards. Responsibilities: Minimum 12+ years' experience as a senior Data Analyst in the healthcare sector. Knowledge of FHIR Excellent skills building source to target mappings using hL7/FHIR messaging protocols, technical and functional requirements and conducting analysis in healthcare setting. Experience analyzing proc

Full-time

Senior RAVE Clinical Database Programmer

Remote or New Jersey

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Today

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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Today

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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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

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

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

Process Engineer

Denver, Colorado

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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

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

Senior Clinical Database Programmer

Boulder, Colorado

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Today

Role Summary: 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. Key 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 Deliver cl

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

Senior Clinical Database Programmer

Boulder, Colorado

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Today

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

Mechanical Design Engineer

Denver, Colorado

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Today

Roles & Responsibilities: Lead new product development from proof-of-concept through design verification for a needle-free drug delivery application, following a stage-gate NPD process Create, refine, and release 3D models and production drawings for disposable and syringe-based components using SolidWorks uthor and maintain Design History Files (DHF) and support audits, inspections, and regulatory compliance activities Ensure adherence to ISO and FDA design control requirements throughout the d

Full-time

jobs in Boulder, CO, USA