jobs in woburn, ma, us

Boston, Massachusetts

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Today

Job Description: Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require. Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, do

Full-time

Validation Engineer

Boston, Massachusetts

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Today

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

Product Design Quality Engineer

Cambridge, Massachusetts

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Today

Job Description: The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requirements, quality standards, and design control processes. This role partners with cross-functional teams to integrate quality into product development, risk management, validation, and manufacturing transfer activities. Responsibilities: Support Design Control activities throughout the product development lifecycle in

Full-time

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

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Today

Job Summary: leading organization is seeking an experienced Pharma IT Testing & Validation Delivery Lead to manage global testing and validation services across multiple Life Sciences programs. Roles & Responsibilities: Own end-to-end testing and validation delivery across multiple pharmaceutical IT projects. Lead onsite and offshore QA teams across the United States, United Kingdom, and India. Define testing strategy, governance, KPIs, delivery standards, and quality metrics. Oversee functional

Full-time

Validations/ Verifications Engineer

Boston, Massachusetts

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Today

Role Descriptions: Must Have Technical/Functional Skills Desirable Skills: Skills: EIS: Medical Device & Regulations ~EIS: New Product Development (NPD) Methodology and Management Experience Required: 4-6 5+ years of work experience in medical device industry Required: A bachelor's degree in Technical or Scientific discipline 5+ years of work experience in medical device industry Experience conducting Process Verifications / Validations Experience conducting Design and/or Process Failure M

Full-time

CSV Engineer

Woburn, Massachusetts

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Today

Job Summary: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer S

Full-time

Validation Engineer

Boxborough, Massachusetts

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Today

Roles & Responsibilities : Test Stand & LabView experience along with some Manufacturing equipment validations (IQ/OQ /PQ) experience Test Engineer that can help qualify Automated Functional Testers. Would be responsible for writing all the documentation (requirement| trace matrix| protocols| reports using the Healthcare templates) and executing the validations. The code for the testers will be written by an internal resources with whom Candidate would work closely in order to complete the paper

Full-time

Senior Validation Engineer Consultant

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

Senior Software Quality Assurance Engineer

Andover, Massachusetts

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Today

Job Description As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and compliance across the product development lifecycle for Class II/ medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commerc

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

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

GxP System Engineer

Norwood, Massachusetts

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Today

Job Summary: We are seeking an experienced GxP System Engineer with strong expertise in Hamilton Instrumentation, laboratory automation systems, and Computer System Validation (CSV) within a regulated pharmaceutical environment. The ideal candidate will support validation, compliance, qualification, and operational activities for critical laboratory systems while ensuring adherence to FDA regulations, GxP guidelines, and data integrity standards. The candidate should possess hands-on experience

Full-time

Senior CQV Engineer/Senior Validation Engineer Consultant

Massachusetts

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Today

Job Summary: 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 Qualif

Full-time

Lab Support Engineer

Waltham, Massachusetts

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Today

Roles& Responsibilities: Provide technical operational support for laboratory-based systems to ensure scientists can perform daily activities efficiently Build, configure, and validate laboratory IT systems and instruments, ensuring proper integration across applications such as LIMs, ELN, CDS, and equipment imaging systems Collaborate cross-functionally with Science, Facilities, Quality, and IT teams to deliver and support new lab technologies and infrastructure Develop basic scripts or auto

Full-time

CQV Engineer

Massachusetts

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Today

Summary : We are looking for hands-on CQV Engineers to support a high-impact biologics project within a GMP-regulated environment. This is a fast-paced opportunity focused purely on execution of validation protocols-ideal for professionals who thrive on the manufacturing floor. Roles & Responsibilities: Execute IQ/OQ protocols for process equipment Perform equipment walkdowns and verify against design Support SIP/CIP cycles, wet testing, and temperature mapping Work with downstream equipment (ch

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

jobs in Woburn, MA, USA